The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Humidifier.
Device ID | K945782 |
510k Number | K945782 |
Device Name: | HUMIDIFIER |
Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
Contact | Richard G Confer |
Correspondent | Richard G Confer RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
Product Code | BTT |
CFR Regulation Number | 868.5450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-25 |
Decision Date | 1996-03-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00606959015210 | K945782 | 000 |
00606959015203 | K945782 | 000 |