The following data is part of a premarket notification filed by Respironics Inc. with the FDA for Simple T Nasal Mask.
Device ID | K120145 |
510k Number | K120145 |
Device Name: | SIMPLE T NASAL MASK |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | RESPIRONICS INC. 1001 MURRY RIDGE LANE Murrysville, PA 15668 |
Contact | Michelle Brinker |
Correspondent | Michelle Brinker RESPIRONICS INC. 1001 MURRY RIDGE LANE Murrysville, PA 15668 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-01-18 |
Decision Date | 2012-03-30 |