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FDA 510(k)

PMD SYSTEM-20

K-Number: K883390 · 1988-10-25

ApplicantDatatek, Inc.
Decision Date1988-10-25
Product CodeKMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PMD SYSTEM-20 is the device name listed in this FDA 510(k) record. The listed applicant is Datatek, Inc.. It received FDA 510(k) clearance on 1988-10-25 under 510(k) number K883390. The device is classified under product code KMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PMD SYSTEM-20?

PMD SYSTEM-20 is a medical device that received FDA 510(k) clearance on 1988-10-25. The listed applicant is Datatek, Inc.. The 510(k) number is K883390.

When did PMD SYSTEM-20 receive FDA 510(k) clearance?

PMD SYSTEM-20 received FDA 510(k) clearance on 1988-10-25, under 510(k) number K883390.

Who is the listed applicant for PMD SYSTEM-20?

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

What is the FDA product code for PMD SYSTEM-20?

The FDA product code for PMD SYSTEM-20 is KMI.

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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Related Devices (Code: KMI)

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.

K131585INTEL-GE CARE INNOVATIONS QUIETCAREIntel-Ge Care Innovations, LLCK130752DYNASENSE SYSTEMCentauri Medical, Inc.K101109VIVATRAKWireless Medcare, LLCK090138MOBILECARE MONITOR, MODEL 2100Aframe Digital, Inc.K942770ULTIMAT-SENSOR FOR BED OCCUPANCY MONITORUltimate Development Corp.K943481INFORMER PLUSMicro-Tech Medical, Inc.

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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