The following data is part of a premarket notification filed by Foremount Enterprise Co., Ltd. with the FDA for Foremount Disposable Pvc Resuscitator, Foremount Disposable Peep Valve, Foremount Disposable Manometer.
| Device ID | K170663 |
| 510k Number | K170663 |
| Device Name: | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | Foremount Enterprise Co., Ltd. No. 17, Alley 15, Lane 5, Shenan St., Shengang Dist., Taichung City, TW 42944 |
| Contact | John Yang |
| Correspondent | Paul Dryden MDVentures 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | BTM |
| Subsequent Product Code | BYE |
| Subsequent Product Code | CAP |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-06 |
| Decision Date | 2018-05-11 |
| Summary: | summary |