The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Fb-18x, Fiber Bronchoscope.
| Device ID | K951199 |
| 510k Number | K951199 |
| Device Name: | FB-18X, FIBER BRONCHOSCOPE |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar, FL 33025 |
| Contact | Paul Silva |
| Correspondent | Paul Silva PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar, FL 33025 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-16 |
| Decision Date | 1995-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333244164 | K951199 | 000 |
| 04961333227259 | K951199 | 000 |
| 04961333224166 | K951199 | 000 |
| 04961333224098 | K951199 | 000 |
| 04961333224081 | K951199 | 000 |
| 04961333195077 | K951199 | 000 |
| 04961333171514 | K951199 | 000 |
| 04961333079346 | K951199 | 000 |
| 04961333083015 | K951199 | 000 |
| 04961333227563 | K951199 | 000 |
| 04961333227624 | K951199 | 000 |
| 04961333227655 | K951199 | 000 |
| 04961333243402 | K951199 | 000 |
| 04961333232697 | K951199 | 000 |
| 04961333232680 | K951199 | 000 |
| 04961333232673 | K951199 | 000 |
| 04961333232666 | K951199 | 000 |
| 04961333232659 | K951199 | 000 |
| 04961333227846 | K951199 | 000 |
| 04961333227747 | K951199 | 000 |
| 04961333070541 | K951199 | 000 |