The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for Devilbiss Model 1400d (oxygen Conserving Device).
Device ID | K890141 |
510k Number | K890141 |
Device Name: | DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE) |
Classification | Conserver, Oxygen |
Applicant | DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
Contact | David Gast |
Correspondent | David Gast DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
Product Code | NFB |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-13 |
Decision Date | 1989-04-06 |