The following data is part of a premarket notification filed by Shaban Mfg. Co. with the FDA for Partial Pressure Electrode Measurement.
| Device ID | K833534 |
| 510k Number | K833534 |
| Device Name: | PARTIAL PRESSURE ELECTRODE MEASUREMENT |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | SHABAN MFG. CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-27 |
| Decision Date | 1983-12-29 |