The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Ventlab Anesthesia Circuit Ac 6000.
Device ID | K896897 |
510k Number | K896897 |
Device Name: | VENTLAB ANESTHESIA CIRCUIT AC 6000 |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | VENTLAB CORP. 221 GRACIE PLACE Hackensack, NJ 07601 |
Contact | Gregory Lau |
Correspondent | Gregory Lau VENTLAB CORP. 221 GRACIE PLACE Hackensack, NJ 07601 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-08 |
Decision Date | 1990-01-26 |