The following data is part of a premarket notification filed by Bawmed Uk with the FDA for Bawmed E-z Bag Resuscitator.
| Device ID | K031434 |
| 510k Number | K031434 |
| Device Name: | BAWMED E-Z BAG RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | BAWMED UK 6 GREAT HOUSE MEADOWS United Kingdom, GB Cf61 Isu. |
| Contact | Barbara Woods |
| Correspondent | Barbara Woods BAWMED UK 6 GREAT HOUSE MEADOWS United Kingdom, GB Cf61 Isu. |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-06 |
| Decision Date | 2004-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814940021434 | K031434 | 000 |
| 00814940021427 | K031434 | 000 |
| 00814940021410 | K031434 | 000 |
| 00814940020079 | K031434 | 000 |
| 00814940020062 | K031434 | 000 |
| 00814940020055 | K031434 | 000 |