The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Browser (event Software) Model # 4500e.
| Device ID | K982550 |
| 510k Number | K982550 |
| Device Name: | BROWSER (EVENT SOFTWARE) MODEL # 4500E |
| Classification | Monitor, Breathing Frequency |
| Applicant | RESPIRONICS, INC. 1501 ARDMORE BLVD. Pittsburgh, PA 15221 -4401 |
| Contact | Betsy Cortelloni |
| Correspondent | Betsy Cortelloni RESPIRONICS, INC. 1501 ARDMORE BLVD. Pittsburgh, PA 15221 -4401 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-22 |
| Decision Date | 1998-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B036101483 | K982550 | 000 |