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FDA 510(k)

SPIROMETER, MONITORING W/ALARM

K-Number: K780064 · 1978-01-31

ApplicantOhio Medical Products
Decision Date1978-01-31
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROMETER, MONITORING W/ALARM is the device name listed in this FDA 510(k) record. The listed applicant is Ohio Medical Products. It received FDA 510(k) clearance on 1978-01-31 under 510(k) number K780064. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIROMETER, MONITORING W/ALARM?

SPIROMETER, MONITORING W/ALARM is a medical device that received FDA 510(k) clearance on 1978-01-31. The listed applicant is Ohio Medical Products. The 510(k) number is K780064.

When did SPIROMETER, MONITORING W/ALARM receive FDA 510(k) clearance?

SPIROMETER, MONITORING W/ALARM received FDA 510(k) clearance on 1978-01-31, under 510(k) number K780064.

Who is the listed applicant for SPIROMETER, MONITORING W/ALARM?

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

What is the FDA product code for SPIROMETER, MONITORING W/ALARM?

The FDA product code for SPIROMETER, MONITORING W/ALARM is BZK.

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Other records listing Ohio Medical Products 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.

K841733OHIO WASTE GAS SCAVENGING RESERVOIRK842003OHIO WASTE GAS SCAVENGING INTERFACEK840356OHIO UNITROL II ANESTHESIA GAS MACHINEK841274BAG-TO-VENTILATOR SELECTOR VALVEK840967OHIO HEAT REFLECTING PATCHK840857OHIO 3000 INFANT WARMER SYSTEM

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Related Devices (Code: BZK)

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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