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FDA 510(k)

SCANNING DIRECTOR

K-Number: K944585 · 1995-02-21

ApplicantPrentke Romich Co.
Decision Date1995-02-21
Product CodeIQA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SCANNING DIRECTOR 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 1995-02-21 under 510(k) number K944585. 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 SCANNING DIRECTOR?

SCANNING DIRECTOR is a medical device that received FDA 510(k) clearance on 1995-02-21. The listed applicant is Prentke Romich Co.. The 510(k) number is K944585.

When did SCANNING DIRECTOR receive FDA 510(k) clearance?

SCANNING DIRECTOR received FDA 510(k) clearance on 1995-02-21, under 510(k) number K944585.

Who is the listed applicant for SCANNING DIRECTOR?

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 SCANNING DIRECTOR?

The FDA product code for SCANNING DIRECTOR is IQA.

Related Clinical Trials

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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.

K961306DELTATALKER WITH INFRAREDK935317ALPHA TALKERK933207WALKERTALKERK925387LIBERATORK925527LIGHT TALKERK914259TOUCH TALKER

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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.

K961306DELTATALKER WITH INFRAREDPrentke Romich Co.K953905IMPERIUMTeledyne Brown EngineeringK953937LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEMApt Technology, Inc.K943244DEUCEApt Technology, Inc.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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