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FDA 510(k)

AMBULARM

K-Number: K840295 · 1984-05-07

ApplicantRigi Systems, Inc.
Decision Date1984-05-07
Product CodeKMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMBULARM is the device name listed in this FDA 510(k) record. The listed applicant is Rigi Systems, Inc.. It received FDA 510(k) clearance on 1984-05-07 under 510(k) number K840295. 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 AMBULARM?

AMBULARM is a medical device that received FDA 510(k) clearance on 1984-05-07. The listed applicant is Rigi Systems, Inc.. The 510(k) number is K840295.

When did AMBULARM receive FDA 510(k) clearance?

AMBULARM received FDA 510(k) clearance on 1984-05-07, under 510(k) number K840295.

Who is the listed applicant for AMBULARM?

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

What is the FDA product code for AMBULARM?

The FDA product code for AMBULARM is KMI.

Related Clinical Trials

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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

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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