Aesculon Chf, Hypertension & Pacemaker Clinic
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070985 FDA 510(k)
- FDA Product Code
- DSB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2770 FDA 510(k)
- Regulation Number
- 870.2770 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aesculon Chf, Hypertension & Pacemaker Clinic is an impedance plethysmograph device. It is intended for the noninvasive continuous monitoring of hemodynamic parameters in adult, pediatric, and neonatal patients.
This device is designed for use in hospitals, hospital-type facilities, mobile, and home environments. It is regulated under FDA 510(k) clearance, identified by k-number K070985.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC (K070985) — FDA 510(k ..., PDF El3OSYPKA MEDICAL 510(k) Summary - accessdata.fda.gov, PDF OSYPKA MEDICAL 510(k) Summary - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070985 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Osypka Medical, Inc.
Sources (1)
- FDA 510(k) K070985 24 fields · synced Sep 26, 2026