The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Corometrics Transcutaneous Tcpo2/co2 Module.
| Device ID | K980756 |
| 510k Number | K980756 |
| Device Name: | COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE |
| Classification | Monitor, Carbon-dioxide, Cutaneous |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Contact | Richard Cehovsky |
| Correspondent | Richard Cehovsky GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Product Code | LKD |
| CFR Regulation Number | 868.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-27 |
| Decision Date | 1998-11-05 |
| Summary: | summary |