GEM-6, WITH COMPONENTS
FDA 510(k) clearance K854357 · decided 1986-01-08
Clearance details
- K-number
- K854357
- Device name
- GEM-6, WITH COMPONENTS
- Applicant
- Diamond Electro-Tech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-10-29
- Decision date
- 1986-01-08
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- DRY
- Device class
- 2
- Regulation number
- 870.4330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.