The following data is part of a premarket notification filed by Bpr Medical, Ltd. with the FDA for Oxygen Demand Valve.
| Device ID | K082345 |
| 510k Number | K082345 |
| Device Name: | OXYGEN DEMAND VALVE |
| Classification | Valve, Non-rebreathing |
| Applicant | BPR MEDICAL, LTD. 22, HAMILTON WAY Mansfield, Nottinghamshire, GB Ng18 5bu |
| Contact | Ben Johnson |
| Correspondent | Ben Johnson BPR MEDICAL, LTD. 22, HAMILTON WAY Mansfield, Nottinghamshire, GB Ng18 5bu |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-15 |
| Decision Date | 2009-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 25060274502692 | K082345 | 000 |
| 05060274500687 | K082345 | 000 |