The following data is part of a premarket notification filed by Galemed Corp. with the FDA for Gio Digital Pressure Guages.
| Device ID | K122627 |
| 510k Number | K122627 |
| Device Name: | GIO DIGITAL PRESSURE GUAGES |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | GALEMED CORP. 29201 VIA NORTE Temecula, CA 92591 |
| Contact | Tom Shanks |
| Correspondent | Tom Shanks GALEMED CORP. 29201 VIA NORTE Temecula, CA 92591 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-28 |
| Decision Date | 2013-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44710810119901 | K122627 | 000 |
| 44710810119899 | K122627 | 000 |
| 44710810119888 | K122627 | 000 |
| 44710810119871 | K122627 | 000 |
| 44710810119895 | K122627 | 000 |
| 04710810119897 | K122627 | 000 |
| 04710810105258 | K122627 | 000 |