The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Ec-384otl, Video Colonscope.
| Device ID | K961563 |
| 510k Number | K961563 |
| Device Name: | EC-384OTL, VIDEO COLONSCOPE |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| 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 | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-23 |
| Decision Date | 1996-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333084692 | K961563 | 000 |
| 04961333072996 | K961563 | 000 |
| 04961333072965 | K961563 | 000 |