The following data is part of a premarket notification filed by The Timeter Group with the FDA for Mp-500 Electronic Nebulizer.
| Device ID | K862171 |
| 510k Number | K862171 |
| Device Name: | MP-500 ELECTRONIC NEBULIZER |
| Classification | Humidifier, Non-direct Patient Interface (home-use) |
| Applicant | THE TIMETER GROUP 2501 OREGON PIKE Lancaster, PA 17601 |
| Contact | Terry L Landis |
| Correspondent | Terry L Landis THE TIMETER GROUP 2501 OREGON PIKE Lancaster, PA 17601 |
| Product Code | KFZ |
| CFR Regulation Number | 868.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-09 |
| Decision Date | 1986-07-14 |