Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SIRECUST 400 SYSTEM PATIENT MONITORING

K-Number: K802113 · 1981-01-22

ApplicantAnalogic Corp.
Decision Date1981-01-22
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIRECUST 400 SYSTEM PATIENT MONITORING is the device name listed in this FDA 510(k) record. The listed applicant is Analogic Corp.. It received FDA 510(k) clearance on 1981-01-22 under 510(k) number K802113. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIRECUST 400 SYSTEM PATIENT MONITORING?

SIRECUST 400 SYSTEM PATIENT MONITORING is a medical device that received FDA 510(k) clearance on 1981-01-22. The listed applicant is Analogic Corp.. The 510(k) number is K802113.

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

SIRECUST 400 SYSTEM PATIENT MONITORING received FDA 510(k) clearance on 1981-01-22, under 510(k) number K802113.

Who is the listed applicant for SIRECUST 400 SYSTEM PATIENT MONITORING?

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 SYSTEM PATIENT MONITORING?

The FDA product code for SIRECUST 400 SYSTEM PATIENT MONITORING is DPS.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 32 devices →

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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.

↑