The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for E5280 Combined Transcutaneous Tcp02/tcpco2 Elect..
| Device ID | K900333 |
| 510k Number | K900333 |
| Device Name: | E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT. |
| Classification | Monitor, Carbon-dioxide, Cutaneous |
| Applicant | RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Contact | Donald Baker |
| Correspondent | Donald Baker RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Product Code | LKD |
| CFR Regulation Number | 868.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-23 |
| Decision Date | 1990-04-16 |