DIGNITY 100
FDA 510(k) clearance K082246 · decided 2008-09-09
Clearance details
- K-number
- K082246
- Device name
- DIGNITY 100
- Applicant
- Dignity Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-08
- Decision date
- 2008-09-09
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.