AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC— 510(k) K070985
Substantially EquivalentOsypka Medical, Inc.
FDA 510(k) clearance K070985 for AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC, Substantially Equivalent on 2008-02-01. Applicant: Osypka Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Osypka Medical, Inc.
- Product code
- Code DSB
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- La Jolla, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.