The following data is part of a premarket notification filed by Medical Technical Gases Inc.. with the FDA for Med-tech Clinical Blood Gas.
| Device ID | K953935 |
| 510k Number | K953935 |
| Device Name: | MED-TECH CLINICAL BLOOD GAS |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | MEDICAL TECHNICAL GASES INC.. 20 HALL ST. Medford, MA 02155 |
| Contact | Ramesh V Kapur |
| Correspondent | Ramesh V Kapur MEDICAL TECHNICAL GASES INC.. 20 HALL ST. Medford, MA 02155 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-18 |
| Decision Date | 1995-11-20 |