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FDA 510(k)

ULTRA IMAGER

K-Number: K827408 · 1982-10-04

ApplicantHoneywell, Inc.
Decision Date1982-10-04
Product Code
DecisionSubstantially Equivalent

Device Summary

ULTRA IMAGER is the device name listed in this FDA 510(k) record. The listed applicant is Honeywell, Inc.. It received FDA 510(k) clearance on 1982-10-04 under 510(k) number K827408. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA IMAGER?

ULTRA IMAGER is a medical device that received FDA 510(k) clearance on 1982-10-04. The listed applicant is Honeywell, Inc.. The 510(k) number is K827408.

When did ULTRA IMAGER receive FDA 510(k) clearance?

ULTRA IMAGER received FDA 510(k) clearance on 1982-10-04, under 510(k) number K827408.

Who is the listed applicant for ULTRA IMAGER?

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

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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Other records listing Honeywell, Inc. 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.

K902230COLORADO COLOR IMAGING RECORDERK863100CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECORK853501HONEYWELL ELECTRONIC VENTILATOR EV-AK855125PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEMK851888APM DISPOS. BLOOD PRESSURE TRANSDUCERK851496ECG MONITOR MODEL RM102

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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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