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FDA 510(k)

NON-INVASIVE, BLOOD PRESSURE MONITOR

K-Number: K801657 · 1980-08-20

ApplicantBiochem International, Inc.
Decision Date1980-08-20
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NON-INVASIVE, BLOOD PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Biochem International, Inc.. It received FDA 510(k) clearance on 1980-08-20 under 510(k) number K801657. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON-INVASIVE, BLOOD PRESSURE MONITOR?

NON-INVASIVE, BLOOD PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 1980-08-20. The listed applicant is Biochem International, Inc.. The 510(k) number is K801657.

When did NON-INVASIVE, BLOOD PRESSURE MONITOR receive FDA 510(k) clearance?

NON-INVASIVE, BLOOD PRESSURE MONITOR received FDA 510(k) clearance on 1980-08-20, under 510(k) number K801657.

Who is the listed applicant for NON-INVASIVE, BLOOD PRESSURE MONITOR?

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

What is the FDA product code for NON-INVASIVE, BLOOD PRESSURE MONITOR?

The FDA product code for NON-INVASIVE, BLOOD PRESSURE MONITOR is DXN.

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Other records listing Biochem International, Inc. as applicant

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K920083BIOCHEM MODEL 3302 NEWOX2 OXIMETERK9323898100 ANESTHETIC AGENT MONITORK921388BIOCHEM 9100 MULTIGAS MONITOR IBP MODULEK920082BIOCHEM MODEL 3301 NEWOX1 OXIMETERK910381BIOCHEM TEMPERATURE/ FIO2 MODULEK911351BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP

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Related Devices (Code: DXN)

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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