The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Ed-344ot.
| Device ID | K961568 |
| 510k Number | K961568 |
| Device Name: | ED-344OT |
| Classification | Duodenoscope And Accessories, Flexible/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 | FDT |
| 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 | 1996-07-09 |
| Summary: | summary |