The following data is part of a premarket notification filed by Galemed Corp. with the FDA for Dispo-bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep Valve.
| Device ID | K082092 |
| 510k Number | K082092 |
| Device Name: | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | GALEMED CORP. 54431 AVENIDA ENCINAS SUITE G Carlsbad, CA 90228 -4411 |
| Contact | Thomas Loescher |
| Correspondent | Thomas Loescher GALEMED CORP. 54431 AVENIDA ENCINAS SUITE G Carlsbad, CA 90228 -4411 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-24 |
| Decision Date | 2008-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44710810101791 | K082092 | 000 |
| 44710810080164 | K082092 | 000 |
| 44710810080157 | K082092 | 000 |
| 44710810085923 | K082092 | 000 |
| 44710810085916 | K082092 | 000 |
| 44710810085909 | K082092 | 000 |
| 44710810085893 | K082092 | 000 |
| 44710810085152 | K082092 | 000 |
| 44710810085145 | K082092 | 000 |
| 44710810085138 | K082092 | 000 |
| 44710810085121 | K082092 | 000 |
| 44710810085114 | K082092 | 000 |
| 44710810085107 | K082092 | 000 |
| 44710810085091 | K082092 | 000 |
| 44710810083684 | K082092 | 000 |
| 44710810083691 | K082092 | 000 |
| 44710810101777 | K082092 | 000 |
| 44710810101753 | K082092 | 000 |
| 44710810093102 | K082092 | 000 |
| 44710810093096 | K082092 | 000 |
| 44710810093089 | K082092 | 000 |
| 44710810093072 | K082092 | 000 |
| 44710810093065 | K082092 | 000 |
| 44710810093058 | K082092 | 000 |
| 44710810093041 | K082092 | 000 |
| 44710810093034 | K082092 | 000 |
| 44710810093027 | K082092 | 000 |
| 44710810093010 | K082092 | 000 |
| 44710810093003 | K082092 | 000 |
| 44710810084902 | K082092 | 000 |