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FDA 510(k)

MODIFIED THER-A-PULSE UNIT

K-Number: K884396 · 1989-05-18

ApplicantWestec Corp.
Decision Date1989-05-18
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODIFIED THER-A-PULSE UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Westec Corp.. It received FDA 510(k) clearance on 1989-05-18 under 510(k) number K884396. 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 MODIFIED THER-A-PULSE UNIT?

MODIFIED THER-A-PULSE UNIT is a medical device that received FDA 510(k) clearance on 1989-05-18. The listed applicant is Westec Corp.. The 510(k) number is K884396.

When did MODIFIED THER-A-PULSE UNIT receive FDA 510(k) clearance?

MODIFIED THER-A-PULSE UNIT received FDA 510(k) clearance on 1989-05-18, under 510(k) number K884396.

Who is the listed applicant for MODIFIED THER-A-PULSE UNIT?

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

What is the FDA product code for MODIFIED THER-A-PULSE UNIT?

The FDA product code for MODIFIED THER-A-PULSE UNIT is IPF.

Related Clinical Trials

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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Other records listing Westec Corp. 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.

K872970THER-A-PULSE

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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