The following data is part of a premarket notification filed by Besmed Health Business Corp. with the FDA for Besmed Reusable Jet Nebulizer.
| Device ID | K150591 |
| 510k Number | K150591 |
| Device Name: | Besmed Reusable Jet Nebulizer |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | BESMED HEALTH BUSINESS CORP. NO.5, LANE116, WU-KONG 2ND RD New Taipei City, TW 24888 |
| Contact | Winnie Chung |
| Correspondent | Paul Dryden BESMED HEALTH BUSINESS CORP. NO.5, LANE116, WU-KONG 2ND RD New Taipei City, TW 24888 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-09 |
| Decision Date | 2015-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840117311961 | K150591 | 000 |
| 00840117308640 | K150591 | 000 |
| 00840117308664 | K150591 | 000 |
| 00840117308688 | K150591 | 000 |
| 00840117311824 | K150591 | 000 |
| 00840117311848 | K150591 | 000 |
| 00840117311862 | K150591 | 000 |
| 00840117311886 | K150591 | 000 |
| 00840117311909 | K150591 | 000 |
| 00840117317994 | K150591 | 000 |
| 00840117311947 | K150591 | 000 |
| 00840117308626 | K150591 | 000 |