The following data is part of a premarket notification filed by Cardiopulmonary Corp. with the FDA for Venturi Ventilator.
Device ID | K943412 |
510k Number | K943412 |
Device Name: | VENTURI VENTILATOR |
Classification | Ventilator, Continuous, Facility Use |
Applicant | CARDIOPULMONARY CORP. 200 CASCADE BLVD. Milford, CT 06460 |
Contact | James W Biondi |
Correspondent | James W Biondi CARDIOPULMONARY CORP. 200 CASCADE BLVD. Milford, CT 06460 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-14 |
Decision Date | 1995-10-16 |