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FDA 510(k)

HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1

K-Number: K902664 · 1990-07-25

ApplicantPrentke Romich Co.
Decision Date1990-07-25
Product CodeIQA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 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 1990-07-25 under 510(k) number K902664. 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 HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1?

HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 is a medical device that received FDA 510(k) clearance on 1990-07-25. The listed applicant is Prentke Romich Co.. The 510(k) number is K902664.

When did HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 receive FDA 510(k) clearance?

HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 received FDA 510(k) clearance on 1990-07-25, under 510(k) number K902664.

Who is the listed applicant for HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1?

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 HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1?

The FDA product code for HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 is IQA.

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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.

K961306DELTATALKER WITH INFRAREDK944585SCANNING DIRECTORK935317ALPHA TALKERK933207WALKERTALKERK925387LIBERATORK925527LIGHT 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.

K961306DELTATALKER WITH INFRAREDPrentke Romich Co.K953905IMPERIUMTeledyne Brown EngineeringK953937LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEMApt Technology, Inc.K943244DEUCEApt Technology, Inc.K944585SCANNING DIRECTORPrentke Romich Co.K944345BEDSIDE BUTLERTrac Medical, 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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