The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Puritan-bennett 840 Ventilator System With Neomode Option.
| Device ID | K001646 |
| 510k Number | K001646 |
| Device Name: | PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
| Contact | Mary E Funk |
| Correspondent | Mary E Funk PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
| 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 | 2000-05-30 |
| Decision Date | 2000-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521643314 | K001646 | 000 |
| 10884521643307 | K001646 | 000 |