The following data is part of a premarket notification filed by Flexicare Medical Limited with the FDA for Adult Single Use Resuscitator Bag Without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40cmh20, Adult Single Use Resuscitator Bag + Pressure Relief 60cmh20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40cmh20, Infa.
| Device ID | K181583 |
| 510k Number | K181583 |
| Device Name: | Adult Single Use Resuscitator Bag Without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infa |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | Flexicare Medical Limited Cynon Valley Business Park Mountain Ash, GB Cf45 4er |
| Contact | Joel Biddle |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-06-15 |
| Decision Date | 2018-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055788790068 | K181583 | 000 |
| 05055931103929 | K181583 | 000 |
| 05055931103943 | K181583 | 000 |
| 05055931103967 | K181583 | 000 |
| 05055931103981 | K181583 | 000 |
| 05055931104001 | K181583 | 000 |
| 05055931104186 | K181583 | 000 |
| 05055931117896 | K181583 | 000 |
| 05055788770268 | K181583 | 000 |
| 05055788770299 | K181583 | 000 |
| 05055788783237 | K181583 | 000 |
| 05055788783244 | K181583 | 000 |
| 05055788790013 | K181583 | 000 |
| 05055788790020 | K181583 | 000 |
| 05055788790037 | K181583 | 000 |
| 05055788790044 | K181583 | 000 |
| 05055788790051 | K181583 | 000 |
| 05055931103882 | K181583 | 000 |