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FDA 510(k)

SPECTRA ECG

K-Number: K915658 · 1992-06-10

ApplicantAdvanced Medical Products, Inc.
Decision Date1992-06-10
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

SPECTRA ECG is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Products, Inc.. It received FDA 510(k) clearance on 1992-06-10 under 510(k) number K915658. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRA ECG?

SPECTRA ECG is a medical device that received FDA 510(k) clearance on 1992-06-10. The listed applicant is Advanced Medical Products, Inc.. The 510(k) number is K915658.

When did SPECTRA ECG receive FDA 510(k) clearance?

SPECTRA ECG received FDA 510(k) clearance on 1992-06-10, under 510(k) number K915658.

Who is the listed applicant for SPECTRA ECG?

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

What is the FDA product code for SPECTRA ECG?

The FDA product code for SPECTRA ECG is LOS.

Related Clinical Trials

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Other records listing Advanced Medical Products, 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.

K000932ARACHNOPHLEBECTOMY NEEDLEK923995URODYNAMICS TUBING KITS #5161, #5150, #7170K921426ULTRA PCIK912925ULTRA PVDK896103MICRO FL 7400 AMBULATORY HOLTER/BP MONITORK896102MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR

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Related Devices (Code: LOS)

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.

K090895EKG-PLUS II SOFTWAREBionet Co., Ltd.K083749CARDIOVIEW32 REVIEW MODULEQrs Diagnostic, LLCK073376PHILIPS ECG ALGORITHMPhilips Medical SystemsK023034CARDIOTOUCH-3000Bionet Company, Ltd.K011328CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPHBionet Company, Ltd.K993616CARDIO-CARD INTERPRETATION SYSTEM INasiff Assoc., 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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