Comaneci, Comaneci Petit, Comaneci 17
FDA 510(k) clearance DEN170064 · decided 2019-04-24
Clearance details
- K-number
- DEN170064
- Device name
- Comaneci, Comaneci Petit, Comaneci 17
- Applicant
- Rapid-Medical , Ltd.
- Decision
- Unknown
- Date received
- 2017-09-28
- Decision date
- 2019-04-24
- Days to decision
- 573 days
- Clearance type
- Direct
- Product code
- PUU
- Device class
- 2
- Regulation number
- 882.5955
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Yokneam, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.