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FDA 510(k)

BIOCHEM 520 BREATH INDICATOR

K-Number: K890874 · 1989-06-15

ApplicantBiochem International, Inc.
Decision Date1989-06-15
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIOCHEM 520 BREATH INDICATOR 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 1989-06-15 under 510(k) number K890874. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCHEM 520 BREATH INDICATOR?

BIOCHEM 520 BREATH INDICATOR is a medical device that received FDA 510(k) clearance on 1989-06-15. The listed applicant is Biochem International, Inc.. The 510(k) number is K890874.

When did BIOCHEM 520 BREATH INDICATOR receive FDA 510(k) clearance?

BIOCHEM 520 BREATH INDICATOR received FDA 510(k) clearance on 1989-06-15, under 510(k) number K890874.

Who is the listed applicant for BIOCHEM 520 BREATH INDICATOR?

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 BIOCHEM 520 BREATH INDICATOR?

The FDA product code for BIOCHEM 520 BREATH INDICATOR is CCK.

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Other records listing Biochem International, 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.

K920083BIOCHEM MODEL 3302 NEWOX2 OXIMETERK9323898100 ANESTHETIC AGENT MONITORK921388BIOCHEM 9100 MULTIGAS MONITOR IBP MODULEK920082BIOCHEM MODEL 3301 NEWOX1 OXIMETERK911351BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBPK910381BIOCHEM TEMPERATURE/ FIO2 MODULE

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Related Devices (Code: CCK)

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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