The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Epm-3300 Video Processor.
| Device ID | K934918 |
| 510k Number | K934918 |
| Device Name: | EPM-3300 VIDEO PROCESSOR |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | Paul Silva |
| Correspondent | Paul Silva PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-15 |
| Decision Date | 1994-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333083701 | K934918 | 000 |
| 04961333169061 | K934918 | 000 |
| 04961333225224 | K934918 | 000 |
| 04961333228188 | K934918 | 000 |
| 04961333228928 | K934918 | 000 |
| 04961333232581 | K934918 | 000 |
| 04961333232611 | K934918 | 000 |
| 04961333232628 | K934918 | 000 |
| 04961333243242 | K934918 | 000 |
| 04961333083084 | K934918 | 000 |