The following data is part of a premarket notification filed by Health & Life Co., Ltd. with the FDA for Ultrasonic Nebulizer System, Model Hl100.
| Device ID | K081738 |
| 510k Number | K081738 |
| Device Name: | ULTRASONIC NEBULIZER SYSTEM, MODEL HL100 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | HEALTH & LIFE CO., LTD. PO BOX 993 A807 EL CAMINO Suit C Carmichael, CA 95609 |
| Contact | Samuel Piper |
| Correspondent | Samuel Piper HEALTH & LIFE CO., LTD. PO BOX 993 A807 EL CAMINO Suit C Carmichael, CA 95609 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-19 |
| Decision Date | 2008-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856702006020 | K081738 | 000 |
| 14719872486036 | K081738 | 000 |
| 24719872486026 | K081738 | 000 |