The following data is part of a premarket notification filed by Shaban Mfg. Co. with the FDA for Cleaning Agent.
Device ID | K823750 |
510k Number | K823750 |
Device Name: | CLEANING AGENT |
Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
Applicant | SHABAN MFG. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CHL |
CFR Regulation Number | 862.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-14 |
Decision Date | 1983-01-14 |