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FDA 510(k)

SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)

K-Number: K964784 · 1997-08-13

ApplicantQuinton, Inc.
Decision Date1997-08-13
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1997-08-13 under 510(k) number K964784. 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 SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)?

SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) is a medical device that received FDA 510(k) clearance on 1997-08-13. The listed applicant is Quinton, Inc.. The 510(k) number is K964784.

When did SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) receive FDA 510(k) clearance?

SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) received FDA 510(k) clearance on 1997-08-13, under 510(k) number K964784.

Who is the listed applicant for SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)?

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

What is the FDA product code for SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)?

The FDA product code for SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) is DPS.

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Other records listing Quinton, 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.

K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601K021906QUINTON Q-CATH, MODEL 000460K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503K001492QUINTON Q-STRESS, MODEL 000483K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)K990866QUINTON MEDTRACK CR PLUS TREADMILL

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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.

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