The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for General Anesthesia System.
Device ID | K945455 |
510k Number | K945455 |
Device Name: | GENERAL ANESTHESIA SYSTEM |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
Contact | Jing Zhang |
Correspondent | Jing Zhang VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-07 |
Decision Date | 1994-12-23 |