CARDIO SERV
FDA 510(k) clearance K951110 · decided 1995-09-15
Clearance details
- K-number
- K951110
- Device name
- CARDIO SERV
- Applicant
- Hellige GmbH
- Decision
- Substantially Equivalent
- Date received
- 1995-03-10
- Decision date
- 1995-09-15
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- LDD
- Device class
- 2
- Regulation number
- 870.5300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- D7800 Freiburg Im Breisga, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.