The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Adapter, C/d Suction.
Device ID | K781713 |
510k Number | K781713 |
Device Name: | ADAPTER, C/D SUCTION |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-10-06 |
Decision Date | 1978-12-12 |