The following data is part of a premarket notification filed by Penlon Ltd. with the FDA for Prima Oxygen Monitor.
| Device ID | K010318 |
| 510k Number | K010318 |
| Device Name: | PRIMA OXYGEN MONITOR |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | PENLON LTD. RADLEY ROAD ABINGDON Oxfordshire, GB Ox14 3ph |
| Contact | Anthony Parsons |
| Correspondent | Anthony Parsons PENLON LTD. RADLEY ROAD ABINGDON Oxfordshire, GB Ox14 3ph |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-02 |
| Decision Date | 2001-07-23 |