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FDA 510(k)

OXYGEN SATURATION METER MODEL NO. SM-1

K-Number: K802847 · 1980-12-16

ApplicantBentley Laboratories, Inc.
Decision Date1980-12-16
Product Code
DecisionSubstantially Equivalent

Device Summary

OXYGEN SATURATION METER MODEL NO. SM-1 is the device name listed in this FDA 510(k) record. The listed applicant is Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1980-12-16 under 510(k) number K802847. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYGEN SATURATION METER MODEL NO. SM-1?

OXYGEN SATURATION METER MODEL NO. SM-1 is a medical device that received FDA 510(k) clearance on 1980-12-16. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K802847.

When did OXYGEN SATURATION METER MODEL NO. SM-1 receive FDA 510(k) clearance?

OXYGEN SATURATION METER MODEL NO. SM-1 received FDA 510(k) clearance on 1980-12-16, under 510(k) number K802847.

Who is the listed applicant for OXYGEN SATURATION METER MODEL NO. SM-1?

The FDA 510(k) record lists Bentley Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Bentley Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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