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FDA 510(k)

PORTABLE MONITORING & SCREENING SPIROM.

K-Number: K822689 · 1983-07-12

ApplicantBoehringer Laboratories
Decision Date1983-07-12
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTABLE MONITORING & SCREENING SPIROM. is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Laboratories. It received FDA 510(k) clearance on 1983-07-12 under 510(k) number K822689. 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 PORTABLE MONITORING & SCREENING SPIROM.?

PORTABLE MONITORING & SCREENING SPIROM. is a medical device that received FDA 510(k) clearance on 1983-07-12. The listed applicant is Boehringer Laboratories. The 510(k) number is K822689.

When did PORTABLE MONITORING & SCREENING SPIROM. receive FDA 510(k) clearance?

PORTABLE MONITORING & SCREENING SPIROM. received FDA 510(k) clearance on 1983-07-12, under 510(k) number K822689.

Who is the listed applicant for PORTABLE MONITORING & SCREENING SPIROM.?

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

What is the FDA product code for PORTABLE MONITORING & SCREENING SPIROM.?

The FDA product code for PORTABLE MONITORING & SCREENING SPIROM. is BZK.

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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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