The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for Pulse Dose Series.
| Device ID | K961126 |
| 510k Number | K961126 |
| Device Name: | PULSE DOSE SERIES |
| Classification | Conserver, Oxygen |
| Applicant | DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Contact | Gregory W Good |
| Correspondent | Gregory W Good 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 | 1996-03-21 |
| Decision Date | 1996-10-21 |
| Summary: | summary |