The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Olympus Lf-tp And Lf-dp Tracheal Intubation Fiberscopes, Accessories And Ancillary Equipment.
| Device ID | K981543 |
| 510k Number | K981543 |
| Device Name: | OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE Melville, NY 11747 -3157 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-30 |
| Decision Date | 1998-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170340215 | K981543 | 000 |
| 04953170340246 | K981543 | 000 |
| 04953170024412 | K981543 | 000 |
| 04953170024429 | K981543 | 000 |
| 04953170051098 | K981543 | 000 |
| 04953170054372 | K981543 | 000 |
| 04953170061998 | K981543 | 000 |
| 04953170062032 | K981543 | 000 |
| 04953170071676 | K981543 | 000 |
| 04953170078798 | K981543 | 000 |
| 04953170136825 | K981543 | 000 |
| 04953170136856 | K981543 | 000 |
| 04953170180767 | K981543 | 000 |
| 04953170340192 | K981543 | 000 |
| 04953170156250 | K981543 | 000 |