The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Achieva Ventilator Y-ach+e, Achieva Ps Ventilator Y-achps+e, Achieva Pso2 Ventilator Y-achps02+e.
Device ID | K002686 |
510k Number | K002686 |
Device Name: | ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E |
Classification | Ventilator, Continuous, Facility Use |
Applicant | NELLCOR PURITAN BENNETT, INC. 2800 NORTHWEST BLVD. Minneapolis, MN 55441 |
Contact | Cheryl Norton |
Correspondent | Cheryl Norton NELLCOR PURITAN BENNETT, INC. 2800 NORTHWEST BLVD. Minneapolis, MN 55441 |
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 | 2000-08-28 |
Decision Date | 2000-10-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884521145665 | K002686 | 000 |
10884521706989 | K002686 | 000 |
10884521706972 | K002686 | 000 |
10884521648524 | K002686 | 000 |