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FDA 510(k)

SIRECUST 400

K-Number: K830029 · 1983-03-31

ApplicantAnalogic Corp.
Decision Date1983-03-31
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIRECUST 400 is the device name listed in this FDA 510(k) record. The listed applicant is Analogic Corp.. It received FDA 510(k) clearance on 1983-03-31 under 510(k) number K830029. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIRECUST 400?

SIRECUST 400 is a medical device that received FDA 510(k) clearance on 1983-03-31. The listed applicant is Analogic Corp.. The 510(k) number is K830029.

When did SIRECUST 400 receive FDA 510(k) clearance?

SIRECUST 400 received FDA 510(k) clearance on 1983-03-31, under 510(k) number K830029.

Who is the listed applicant for SIRECUST 400?

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

What is the FDA product code for SIRECUST 400?

The FDA product code for SIRECUST 400 is DSI.

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Other records listing Analogic Corp. 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.

K071430SYNERAD OMNI, MODELS AN6255 AND AN6265K052447SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600K050919LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423PK043025SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250K041434C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORSK041376C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A

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Related Devices (Code: DSI)

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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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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