Headquarters
Icare Clinical Systems
1200 Harbor Boulevard, Suite 400
Weehawken, NJ 07086, USA
FDA establishment registration is product-specific. Request the current listing with your quote.
Contact
Route monitoring, dental, laboratory, service, or regulatory documentation requests with the context your value-analysis committee needs. Since the 2016 first multi-parameter monitor release and the 2025 Unified Spec Library launch, buyers typically ask for 510(k) substantial equivalence summaries, unique device identification (UDI) CSV exports, HL7 FHIR messaging notes, and post-market surveillance (PMS) templates in the same packet.
Icare Clinical Systems
1200 Harbor Boulevard, Suite 400
Weehawken, NJ 07086, USA
FDA establishment registration is product-specific. Request the current listing with your quote.
Clinical applications: +1-800-ICA-RE31
Field service: +1-800-ICA-RE32
Email: [email protected]
UDI look-up and GPO contract codes available on request.
Sales & applications: Mon–Fri 08:00–18:00 ET
Platinum FSE desk: 24×7
Regulatory docs: Mon–Fri 09:00–17:00 ET
ISO 13485 / CE MDR / HIPAA BAA / post-market surveillance (PMS) templates available via Spec Library. Request clinical evaluation report (CER) excerpts by catalog number.
Share care setting, bed or assay volume, required interfaces (Epic / Cerner ADT, LIS ORM/ORU, DICOM for CBCT), and whether your committee is weighing single-use device (SUD) economics against reusable reprocessing validation. We return a TCO worksheet, service-tier map, and IFU index within two business days. Operating limits remain product-specific: SpO2 accuracy depends on perfusion; wearable battery runtime is typically 8 hours continuous monitoring under the validated profile; analyzer CV / LOD are assay-lot dependent.
Quote / demo request
Include care setting, bed or assay volume, and required interfaces so we can attach the correct IFU and service tier.