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FDA 510(k)

SPIROVIT, MODEL SP-250

K-Number: K984031 · 1999-04-30

ApplicantSchiller AG
Decision Date1999-04-30
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROVIT, MODEL SP-250 is the device name listed in this FDA 510(k) record. The listed applicant is Schiller AG. It received FDA 510(k) clearance on 1999-04-30 under 510(k) number K984031. 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, MODEL SP-250?

SPIROVIT, MODEL SP-250 is a medical device that received FDA 510(k) clearance on 1999-04-30. The listed applicant is Schiller AG. The 510(k) number is K984031.

When did SPIROVIT, MODEL SP-250 receive FDA 510(k) clearance?

SPIROVIT, MODEL SP-250 received FDA 510(k) clearance on 1999-04-30, under 510(k) number K984031.

Who is the listed applicant for SPIROVIT, MODEL SP-250?

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, MODEL SP-250?

The FDA product code for SPIROVIT, MODEL SP-250 is BZG.

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Other records listing Schiller AG as applicant

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Related Devices (Code: BZG)

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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