The following data is part of a premarket notification filed by Innovative Medical Systems, Inc. with the FDA for Hemoglobinometer Model 720 B.
Device ID | K781361 |
510k Number | K781361 |
Device Name: | HEMOGLOBINOMETER MODEL 720 B |
Classification | System, Hemoglobin, Automated |
Applicant | INNOVATIVE MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GKR |
CFR Regulation Number | 864.5620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-08-07 |
Decision Date | 1978-09-14 |