MEDILOG DARWIN HOLTER ANALYSIS
FDA 510(k) clearance K053369 · decided 2005-12-22
Clearance details
- K-number
- K053369
- Device name
- MEDILOG DARWIN HOLTER ANALYSIS
- Applicant
- Huntleigh Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2005-12-05
- Decision date
- 2005-12-22
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Surrey, GB
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.