HEMOGLOBINOMETER MODEL 720 B— 510(k) K781361

Name: FDA 510(k) clearance K781361
Creator: U.S. Food and Drug Administration
Published: 1978-09-14

Substantially Equivalent

Innovative Medical Systems, Inc.

FDA 510(k) clearance K781361 for HEMOGLOBINOMETER MODEL 720 B, Substantially Equivalent on 1978-09-14. Applicant: Innovative Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Innovative Medical Systems, Inc.
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 1978-08-07
Decision date: 1978-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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