The following data is part of a premarket notification filed by P.k. Morgan Ltd. with the FDA for Oxylog 2.
| Device ID | K954731 |
| 510k Number | K954731 |
| Device Name: | OXYLOG 2 |
| Classification | Computer, Oxygen-uptake |
| Applicant | P.K. MORGAN LTD. 4 BLOORS LANE Kent Rainham Me8 7ed, GB |
| Contact | R. H Kernaghan |
| Correspondent | R. H Kernaghan P.K. MORGAN LTD. 4 BLOORS LANE Kent Rainham Me8 7ed, GB |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-16 |
| Decision Date | 1997-01-06 |