V-808 ATOM TRANSCAPSULE
FDA 510(k) clearance K061071 · decided 2006-08-29
Clearance details
- K-number
- K061071
- Device name
- V-808 ATOM TRANSCAPSULE
- Applicant
- Atom Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-17
- Decision date
- 2006-08-29
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- FPL
- Device class
- 2
- Regulation number
- 880.5410
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Ivyland, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.