MULTICHECK

Oximeter To Measure Hemoglobin

RADIOMETER AMERICA, INC.

The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Multicheck.

Pre-market Notification Details

• Device ID: K952725
• 510k Number: K952725
• Device Name: MULTICHECK
• Classification: Oximeter To Measure Hemoglobin
• Applicant: RADIOMETER AMERICA, INC. 810 SHARON DR. Westlake, OH 44145 -1598
• Contact: Donald L Baker
• Correspondent: Donald L Baker; RADIOMETER AMERICA, INC. 810 SHARON DR. Westlake, OH 44145 -1598
• Product Code: GLY
• CFR Regulation Number: 864.7500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-06-14
• Decision Date: 1996-02-20