The following data is part of a premarket notification filed by Bpr Medical, Ltd. with the FDA for Babycare Neo2 Oxygen Concentration Controller.
| Device ID | K943797 |
| 510k Number | K943797 |
| Device Name: | BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | BPR MEDICAL, LTD. OAKHAM BUSINESS PARK HAMILTON WAY Mansfield, Notts. England, GB Ng18 5bu |
| Contact | Richard D Radford |
| Correspondent | Richard D Radford BPR MEDICAL, LTD. OAKHAM BUSINESS PARK HAMILTON WAY Mansfield, Notts. England, GB Ng18 5bu |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-03 |
| Decision Date | 1995-05-11 |