The following data is part of a premarket notification filed by Graham-field, Inc. with the FDA for John Bunn Neb-u-lite Ii Medication Compressor With Disposable Nebulizer, Model #jbo-112-009.
| Device ID | K970035 |
| 510k Number | K970035 |
| Device Name: | JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | GRAHAM-FIELD, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk GRAHAM-FIELD, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-03 |
| Decision Date | 1997-04-01 |
| Summary: | summary |