FI-10M
FDA 510(k) clearance K951194 · decided 1995-04-06
Clearance details
- K-number
- K951194
- Device name
- FI-10M
- Applicant
- Pentax Precision Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-16
- Decision date
- 1995-04-06
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- CAL
- Device class
- 1
- Regulation number
- 868.5530
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Miramar, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FI-10P (K951195) | Pentax Precision Instrument Corp. | 1995-04-06 |
| HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. (K872895) | Haemonetics Corp. | 1988-01-11 |
| REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11 (K852994) | Reichert-Jung, Inc. | 1985-07-29 |
| OLYMPUS LF-1 INTUBATION SCOPE (K850978) | Olympus Corp. | 1985-05-23 |
| AO FLEXIBLE LARYNGOSCOPE, #LS-7 (K802331) | American Optical Corp. | 1980-10-10 |
| AO STYLET LARYNGOSCOPE MODEL SLS (K801364) | American Optical Corp. | 1980-06-17 |
| AO STYLET LARYNGOSCOPE, MODEL SLS-1 (K791634) | American Optical Corp. | 1979-09-17 |
Recalls involving this device
No recalls on record reference this clearance.