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FDA 510(k)

VERSATELL; VERSATELL-S

K-Number: K941959 · 1995-06-21

ApplicantProgressive Concepts, Inc.
Decision Date1995-06-21
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VERSATELL; VERSATELL-S 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 1995-06-21 under 510(k) number K941959. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSATELL; VERSATELL-S?

VERSATELL; VERSATELL-S is a medical device that received FDA 510(k) clearance on 1995-06-21. The listed applicant is Progressive Concepts, Inc.. The 510(k) number is K941959.

When did VERSATELL; VERSATELL-S receive FDA 510(k) clearance?

VERSATELL; VERSATELL-S received FDA 510(k) clearance on 1995-06-21, under 510(k) number K941959.

Who is the listed applicant for VERSATELL; VERSATELL-S?

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 VERSATELL; VERSATELL-S?

The FDA product code for VERSATELL; VERSATELL-S is HCC.

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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.

K940600STIMULATOR, NERVE, TRANSCUTANEOUS, (PAIN RELIEF) 84-GZJK946298BIOSTIM-HVK940349NEUROMUSCULAR ELECTRICAL STIMULATOR

Related Devices (Code: HCC)

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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