BODYSTAT
FDA 510(k) clearance K002835 · decided 2001-07-03
Clearance details
- K-number
- K002835
- Device name
- BODYSTAT
- Applicant
- Bodystat , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-09-12
- Decision date
- 2001-07-03
- Days to decision
- 294 days
- Clearance type
- Traditional
- Product code
- MNW
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- British Isles, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.