The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for Peak Expiratory Flow Meter, Kn-9710.
| Device ID | K092335 |
| 510k Number | K092335 |
| Device Name: | PEAK EXPIRATORY FLOW METER, KN-9710 |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., WU KU INDUSTRIAL PARK Taipei Hsien, TW 248 |
| Contact | Jason Cheng |
| Correspondent | Jason Cheng K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., WU KU INDUSTRIAL PARK Taipei Hsien, TW 248 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-04 |
| Decision Date | 2010-04-09 |
| Summary: | summary |