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FDA 510(k)

SPACELABS MODEL 90201 HOLTER RECORDER

K-Number: K844940 · 1985-02-14

ApplicantSpacelabs, Inc.
Decision Date1985-02-14
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPACELABS MODEL 90201 HOLTER RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1985-02-14 under 510(k) number K844940. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACELABS MODEL 90201 HOLTER RECORDER?

SPACELABS MODEL 90201 HOLTER RECORDER is a medical device that received FDA 510(k) clearance on 1985-02-14. The listed applicant is Spacelabs, Inc.. The 510(k) number is K844940.

When did SPACELABS MODEL 90201 HOLTER RECORDER receive FDA 510(k) clearance?

SPACELABS MODEL 90201 HOLTER RECORDER received FDA 510(k) clearance on 1985-02-14, under 510(k) number K844940.

Who is the listed applicant for SPACELABS MODEL 90201 HOLTER RECORDER?

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 SPACELABS MODEL 90201 HOLTER RECORDER?

The FDA product code for SPACELABS MODEL 90201 HOLTER RECORDER is DSH.

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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: DSH)

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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