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 |