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FDA 510(k)

DELTATALKER WITH INFRARED

K-Number: K961306 · 1996-06-27

ApplicantPrentke Romich Co.
Decision Date1996-06-27
Product CodeIQA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DELTATALKER WITH INFRARED 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 1996-06-27 under 510(k) number K961306. The device is classified under product code IQA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELTATALKER WITH INFRARED?

DELTATALKER WITH INFRARED is a medical device that received FDA 510(k) clearance on 1996-06-27. The listed applicant is Prentke Romich Co.. The 510(k) number is K961306.

When did DELTATALKER WITH INFRARED receive FDA 510(k) clearance?

DELTATALKER WITH INFRARED received FDA 510(k) clearance on 1996-06-27, under 510(k) number K961306.

Who is the listed applicant for DELTATALKER WITH INFRARED?

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 DELTATALKER WITH INFRARED?

The FDA product code for DELTATALKER WITH INFRARED is IQA.

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 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.

K944585SCANNING DIRECTORK935317ALPHA TALKERK933207WALKERTALKERK925387LIBERATORK925527LIGHT TALKERK914259TOUCH TALKER

View all 9 devices →

Related Devices (Code: IQA)

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.

K953905IMPERIUMTeledyne Brown EngineeringK953937LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEMApt Technology, Inc.K943244DEUCEApt Technology, Inc.K944585SCANNING DIRECTORPrentke Romich Co.K944345BEDSIDE BUTLERTrac Medical, Inc.K940223LEARN MODE WATERPROOF PENDANT PANIC BUTTONInteractive Technologies, Inc.

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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