The following data is part of a premarket notification filed by Dantec Electronics, Inc. with the FDA for Dantec 22k60/61/62 Catheter Tip Transducer.
| Device ID | K884915 |
| 510k Number | K884915 |
| Device Name: | DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale, NJ 07401 |
| Contact | T Quigley |
| Correspondent | T Quigley DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale, NJ 07401 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-28 |
| Decision Date | 1989-10-04 |