The following data is part of a premarket notification filed by Shaban Mfg. Co. with the FDA for Membrane Kits-kc1, Co2 & 02 For Instrument-lab.
| Device ID | K844781 |
| 510k Number | K844781 |
| Device Name: | MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | SHABAN MFG. CO. 3052 METRO PKWY. Fort Myers, FL 33901 |
| Contact | Barbara H Sneade |
| Correspondent | Barbara H Sneade SHABAN MFG. CO. 3052 METRO PKWY. Fort Myers, FL 33901 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-10 |
| Decision Date | 1985-02-01 |