The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Golife Nasal Mask.
Device ID | K102502 |
510k Number | K102502 |
Device Name: | GOLIFE NASAL MASK |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | RESPIRONICS, INC. 365 PLUM INDUSTRIAL COURT Pittsburgh, PA 15239 |
Contact | Michelle Brinker |
Correspondent | Michelle Brinker RESPIRONICS, INC. 365 PLUM INDUSTRIAL COURT Pittsburgh, PA 15239 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-01 |
Decision Date | 2010-12-22 |
Summary: | summary |