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FDA 510(k)

PULSE CARDULE (MODEL 1859/1860 ECG)

K-Number: K760120 · 1976-07-20

ApplicantSpacelabs, Inc.
Decision Date1976-07-20
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PULSE CARDULE (MODEL 1859/1860 ECG) is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1976-07-20 under 510(k) number K760120. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSE CARDULE (MODEL 1859/1860 ECG)?

PULSE CARDULE (MODEL 1859/1860 ECG) is a medical device that received FDA 510(k) clearance on 1976-07-20. The listed applicant is Spacelabs, Inc.. The 510(k) number is K760120.

When did PULSE CARDULE (MODEL 1859/1860 ECG) receive FDA 510(k) clearance?

PULSE CARDULE (MODEL 1859/1860 ECG) received FDA 510(k) clearance on 1976-07-20, under 510(k) number K760120.

Who is the listed applicant for PULSE CARDULE (MODEL 1859/1860 ECG)?

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

What is the FDA product code for PULSE CARDULE (MODEL 1859/1860 ECG)?

The FDA product code for PULSE CARDULE (MODEL 1859/1860 ECG) is DRT.

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Other records listing Spacelabs, 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.

K954962SPACELABS MEDICAL MULTIGAS ANALYZERK951605SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEMK950779HEART RATE VARIABILITY SOFTWARE OPTIONK941165COMET CAPNOGRAPH MODULEK923788SPACE LABS MODEL 90560K912742ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE

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Related Devices (Code: DRT)

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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