The following data is part of a premarket notification filed by Salter Labs with the FDA for Challenger Dosimeter.
| Device ID | K870755 |
| 510k Number | K870755 |
| Device Name: | CHALLENGER DOSIMETER |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
| Contact | James N Curti |
| Correspondent | James N Curti SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-26 |
| Decision Date | 1987-03-16 |