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FDA 510(k)

SPIROMETER ISOLATION VALVE #8890

K-Number: K833088 · 1983-10-28

ApplicantBoehringer Mannheim Corp.
Decision Date1983-10-28
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROMETER ISOLATION VALVE #8890 is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1983-10-28 under 510(k) number K833088. The device is classified under product code CAI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIROMETER ISOLATION VALVE #8890?

SPIROMETER ISOLATION VALVE #8890 is a medical device that received FDA 510(k) clearance on 1983-10-28. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K833088.

When did SPIROMETER ISOLATION VALVE #8890 receive FDA 510(k) clearance?

SPIROMETER ISOLATION VALVE #8890 received FDA 510(k) clearance on 1983-10-28, under 510(k) number K833088.

Who is the listed applicant for SPIROMETER ISOLATION VALVE #8890?

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

What is the FDA product code for SPIROMETER ISOLATION VALVE #8890?

The FDA product code for SPIROMETER ISOLATION VALVE #8890 is CAI.

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Other records listing Boehringer Mannheim Corp. as applicant

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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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