The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Disposable Vvc(volume Ventilator Circuit).
Device ID | K852821 |
510k Number | K852821 |
Device Name: | DISPOSABLE VVC(VOLUME VENTILATOR CIRCUIT) |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Contact | Hartley C Ericson |
Correspondent | Hartley C Ericson PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-02 |
Decision Date | 1985-07-29 |