INSTRUMENTARIUM ULF MR IMAGING SYSTEM
FDA premarket approval P860010/S002 · decided 1987-05-26
Approval details
- PMA number
- P860010
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- INSTRUMENTARIUM ULF MR IMAGING SYSTEM
- Generic name
- System, nuclear magnetic resonance imaging
- Applicant
- Palomex Instrumentarium Corp.
- Date received
- 1987-04-20
- Decision date
- 1987-05-26
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- LNH
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Helsinki, TX
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE (K872734) | Palomex Instrumentarium Corp. | 1987-10-08 |