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FDA 510(k)

PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM

K-Number: K972255 · 1998-07-07

ApplicantPulse Biomedical, Inc.
Decision Date1998-07-07
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pulse Biomedical, Inc.. It received FDA 510(k) clearance on 1998-07-07 under 510(k) number K972255. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM?

PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-07-07. The listed applicant is Pulse Biomedical, Inc.. The 510(k) number is K972255.

When did PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM receive FDA 510(k) clearance?

PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM received FDA 510(k) clearance on 1998-07-07, under 510(k) number K972255.

Who is the listed applicant for PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM?

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

What is the FDA product code for PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM?

The FDA product code for PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM is LOS.

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 Pulse Biomedical, 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.

K100813QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USBK042799QRS-CARD CARDIOLOGY SUITE

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

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