The following data is part of a premarket notification filed by Nidek Medical Products, Inc. with the FDA for Pulmo-mist Compressor Model # 4323.
| Device ID | K020797 |
| 510k Number | K020797 |
| Device Name: | PULMO-MIST COMPRESSOR MODEL # 4323 |
| Classification | Compressor, Air, Portable |
| Applicant | NIDEK MEDICAL PRODUCTS, INC. 3949 VALLEY EAST INDUSTRIAL DR Birmingham, AL 35217 |
| Contact | L. G Suelter |
| Correspondent | Pamlea K Gwynn UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | BTI |
| CFR Regulation Number | 868.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-03-12 |
| Decision Date | 2002-05-03 |
| Summary: | summary |