AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2— 510(k) K081035
Substantially EquivalentOsypka Medical, Inc.
FDA 510(k) clearance K081035 for AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2, Substantially Equivalent on 2008-05-30. 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
- Special
- Location
- La Jolla, CA, US
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