The following data is part of a premarket notification filed by David Medical Products Co.,ltd with the FDA for Pvc And Silicone Manual Resuscitators.
| Device ID | K051177 |
| 510k Number | K051177 |
| Device Name: | PVC AND SILICONE MANUAL RESUSCITATORS |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | DAVID MEDICAL PRODUCTS CO.,LTD 88 FUDA RD. LUDU Taicang,suzhou,jiangsu, CN 215412 |
| Contact | David Lu |
| Correspondent | David Lu DAVID MEDICAL PRODUCTS CO.,LTD 88 FUDA RD. LUDU Taicang,suzhou,jiangsu, CN 215412 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-06 |
| Decision Date | 2005-08-29 |