The following data is part of a premarket notification filed by Galemed Corp. with the FDA for Galemed Peak Flow Meter, Models 3751/3752.
| Device ID | K022124 |
| 510k Number | K022124 |
| Device Name: | GALEMED PEAK FLOW METER, MODELS 3751/3752 |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | GALEMED CORP. 87, LI-GONG 2ND RD., Wu-jia, I-lan, TW 268 |
| Contact | Bruce Kuo |
| Correspondent | Bruce Kuo GALEMED CORP. 87, LI-GONG 2ND RD., Wu-jia, I-lan, TW 268 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-01 |
| Decision Date | 2003-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44710810085688 | K022124 | 000 |
| 44710810084605 | K022124 | 000 |
| 44710810083035 | K022124 | 000 |