The following data is part of a premarket notification filed by Puritan-bennett with the FDA for Puritan-bennett 840 Ventilatior System With Volume Ventilation Plus Option.
Device ID | K021573 |
510k Number | K021573 |
Device Name: | PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION |
Classification | Ventilator, Continuous, Facility Use |
Applicant | PURITAN-BENNETT 2200 FARADAY AVE. Carlsbad, CA 92008 |
Contact | Gina To |
Correspondent | Gina To PURITAN-BENNETT 2200 FARADAY AVE. Carlsbad, CA 92008 |
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 | 2002-05-14 |
Decision Date | 2002-08-13 |
Summary: | summary |