GAMMA GUIDANCE SYSTEM
FDA 510(k) clearance K961321 · decided 1997-02-10
Clearance details
- K-number
- K961321
- Device name
- GAMMA GUIDANCE SYSTEM
- Applicant
- Radiation Monitoring Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-05
- Decision date
- 1997-02-10
- Days to decision
- 311 days
- Clearance type
- Traditional
- Product code
- IZD
- Device class
- 1
- Regulation number
- 892.1320
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Watertown, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.