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FDA 510(k)

WALKERTALKER

K-Number: K933207 · 1994-03-28

ApplicantPrentke Romich Co.
Decision Date1994-03-28
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

WALKERTALKER is the device name listed in this FDA 510(k) record. The listed applicant is Prentke Romich Co.. It received FDA 510(k) clearance on 1994-03-28 under 510(k) number K933207. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the WALKERTALKER?

WALKERTALKER is a medical device that received FDA 510(k) clearance on 1994-03-28. The listed applicant is Prentke Romich Co.. The 510(k) number is K933207.

When did WALKERTALKER receive FDA 510(k) clearance?

WALKERTALKER received FDA 510(k) clearance on 1994-03-28, under 510(k) number K933207.

Who is the listed applicant for WALKERTALKER?

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

What is the FDA product code for WALKERTALKER?

The FDA product code for WALKERTALKER is ITI.

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Other records listing Prentke Romich Co. 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: ITI)

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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