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FDA 510(k)

BIOSTIM-HV

K-Number: K946298 · 1995-05-11

ApplicantProgressive Concepts, Inc.
Decision Date1995-05-11
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIOSTIM-HV is the device name listed in this FDA 510(k) record. The listed applicant is Progressive Concepts, Inc.. It received FDA 510(k) clearance on 1995-05-11 under 510(k) number K946298. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSTIM-HV?

BIOSTIM-HV is a medical device that received FDA 510(k) clearance on 1995-05-11. The listed applicant is Progressive Concepts, Inc.. The 510(k) number is K946298.

When did BIOSTIM-HV receive FDA 510(k) clearance?

BIOSTIM-HV received FDA 510(k) clearance on 1995-05-11, under 510(k) number K946298.

Who is the listed applicant for BIOSTIM-HV?

The FDA 510(k) record lists Progressive Concepts, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSTIM-HV?

The FDA product code for BIOSTIM-HV is IPF.

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Other records listing Progressive Concepts, Inc. 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.

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Related Devices (Code: IPF)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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