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FDA 510(k)

HEMATOCRIT-SATURATION MONITOR HSM-100

K-Number: K852124 · 1985-09-16

ApplicantAmerican Bentley
Decision Date1985-09-16
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEMATOCRIT-SATURATION MONITOR HSM-100 is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1985-09-16 under 510(k) number K852124. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMATOCRIT-SATURATION MONITOR HSM-100?

HEMATOCRIT-SATURATION MONITOR HSM-100 is a medical device that received FDA 510(k) clearance on 1985-09-16. The listed applicant is American Bentley. The 510(k) number is K852124.

When did HEMATOCRIT-SATURATION MONITOR HSM-100 receive FDA 510(k) clearance?

HEMATOCRIT-SATURATION MONITOR HSM-100 received FDA 510(k) clearance on 1985-09-16, under 510(k) number K852124.

Who is the listed applicant for HEMATOCRIT-SATURATION MONITOR HSM-100?

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

What is the FDA product code for HEMATOCRIT-SATURATION MONITOR HSM-100?

The FDA product code for HEMATOCRIT-SATURATION MONITOR HSM-100 is DRY.

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Related Devices (Code: DRY)

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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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