K802847Substantially Equivalent

Oxygen Saturation Meter Model No. Sm-1

Name: K802847 Oxygen Saturation Meter Model No. Sm-1
Creator: Bentley Laboratories, Inc.
Published: 1980-12-16
License: https://open.fda.gov/license/

Bentley Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K802847 is the FDA 510(k) clearance record for OXYGEN SATURATION METER MODEL NO. SM-1, cleared for Bentley Laboratories, Inc. on 1980-12-16. FDA records list 55 510(k) clearances for Bentley Laboratories, Inc., from 1976-08-06 to 1993-07-13. As of 2026-09-10, FDA records show no recalls naming K802847.

Clearance record

Decision date: 1980-12-16
Received: 1980-11-12 (34 days to decision)
Review panel: Unknown
Applicant: Bentley Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No