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FDA 510(k)

SPIROVIT SP-2, PNEUMOCHECK II

K-Number: K992823 · 2000-05-12

ApplicantSchiller AG
Decision Date2000-05-12
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROVIT SP-2, PNEUMOCHECK II is the device name listed in this FDA 510(k) record. The listed applicant is Schiller AG. It received FDA 510(k) clearance on 2000-05-12 under 510(k) number K992823. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIROVIT SP-2, PNEUMOCHECK II?

SPIROVIT SP-2, PNEUMOCHECK II is a medical device that received FDA 510(k) clearance on 2000-05-12. The listed applicant is Schiller AG. The 510(k) number is K992823.

When did SPIROVIT SP-2, PNEUMOCHECK II receive FDA 510(k) clearance?

SPIROVIT SP-2, PNEUMOCHECK II received FDA 510(k) clearance on 2000-05-12, under 510(k) number K992823.

Who is the listed applicant for SPIROVIT SP-2, PNEUMOCHECK II?

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

What is the FDA product code for SPIROVIT SP-2, PNEUMOCHECK II?

The FDA product code for SPIROVIT SP-2, PNEUMOCHECK II is BZG.

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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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