The following data is part of a premarket notification filed by Cardiopulmonary Corp. with the FDA for Modification Of Venturi Ventilator.
Device ID | K990429 |
510k Number | K990429 |
Device Name: | MODIFICATION OF VENTURI VENTILATOR |
Classification | Ventilator, Continuous, Facility Use |
Applicant | CARDIOPULMONARY CORP. 200 CASCADE BLVD. Milford, CT 06460 |
Contact | John Laviola |
Correspondent | John Laviola CARDIOPULMONARY CORP. 200 CASCADE BLVD. Milford, CT 06460 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-11 |
Decision Date | 1999-02-24 |