The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Spirometer Model Npb-500.
| Device ID | K980441 |
| 510k Number | K980441 |
| Device Name: | SPIROMETER MODEL NPB-500 |
| Classification | Spirometer, Diagnostic |
| Applicant | NELLCOR PURITAN BENNETT, INC. 11150 THOMPSON AVE. Lenexa, KS 66219 -2301 |
| Contact | David Green |
| Correspondent | David Green NELLCOR PURITAN BENNETT, INC. 11150 THOMPSON AVE. Lenexa, KS 66219 -2301 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-04 |
| Decision Date | 1998-04-30 |
| Summary: | summary |