The following data is part of a premarket notification filed by Healthline Medical with the FDA for Medicator Aerosol Drug Delivery System.
| Device ID | K960397 |
| 510k Number | K960397 |
| Device Name: | MEDICATOR AEROSOL DRUG DELIVERY SYSTEM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | HEALTHLINE MEDICAL 4610 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Contact | Russell W King |
| Correspondent | Russell W King HEALTHLINE MEDICAL 4610 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-29 |
| Decision Date | 1996-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857863007789 | K960397 | 000 |
| 00850022357756 | K960397 | 000 |
| 00857863007277 | K960397 | 000 |
| 00857863007284 | K960397 | 000 |
| 00857863007291 | K960397 | 000 |
| 00857863007321 | K960397 | 000 |
| 00857863007307 | K960397 | 000 |
| 00857863007314 | K960397 | 000 |
| 00857863007352 | K960397 | 000 |
| 00857863007383 | K960397 | 000 |
| 00857863007796 | K960397 | 000 |
| 10857863007724 | K960397 | 000 |
| 00857863007802 | K960397 | 000 |
| 00857863007826 | K960397 | 000 |
| 00850022357732 | K960397 | 000 |