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FDA 510(k)

BED-CHECK: II-IFAC

K-Number: K823926 · 1983-04-18

ApplicantBed-Check Corp.
Decision Date1983-04-18
Product CodeKMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BED-CHECK: II-IFAC is the device name listed in this FDA 510(k) record. The listed applicant is Bed-Check Corp.. It received FDA 510(k) clearance on 1983-04-18 under 510(k) number K823926. 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 BED-CHECK: II-IFAC?

BED-CHECK: II-IFAC is a medical device that received FDA 510(k) clearance on 1983-04-18. The listed applicant is Bed-Check Corp.. The 510(k) number is K823926.

When did BED-CHECK: II-IFAC receive FDA 510(k) clearance?

BED-CHECK: II-IFAC received FDA 510(k) clearance on 1983-04-18, under 510(k) number K823926.

Who is the listed applicant for BED-CHECK: II-IFAC?

The FDA 510(k) record lists Bed-Check Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BED-CHECK: II-IFAC?

The FDA product code for BED-CHECK: II-IFAC is KMI.

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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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