The following data is part of a premarket notification filed by Enter Medical Corporation with the FDA for Shineball Pvc Manual Resusciator, Ent-1001, Ent-1003, Ent-1005, Shineball Silicone Manual Resusciator, Ent-1022,.
| Device ID | K042556 |
| 510k Number | K042556 |
| Device Name: | SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022, |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | ENTER MEDICAL CORPORATION NO.16-1, LANE 564 WEN HUA SAN ROAD Gui Shan Xiang,tao Yuan Hsien, TW 333 |
| Contact | Tzong-fuh Kuo |
| Correspondent | Tzong-fuh Kuo ENTER MEDICAL CORPORATION NO.16-1, LANE 564 WEN HUA SAN ROAD Gui Shan Xiang,tao Yuan Hsien, TW 333 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-20 |
| Decision Date | 2005-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872109631 | K042556 | 000 |
| 04719872104568 | K042556 | 000 |