The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Ionometer Eh-hk And Accessories.
Device ID | K901041 |
510k Number | K901041 |
Device Name: | IONOMETER EH-HK AND ACCESSORIES |
Classification | Electrode, Ion Specific, Potassium |
Applicant | FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
Contact | Thomas E Cane |
Correspondent | Thomas E Cane FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
Product Code | CEM |
CFR Regulation Number | 862.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-06 |
Decision Date | 1990-06-18 |