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FDA 510(k)

SPACELABS MODEL 90900

K-Number: K894093 · 1989-11-30

ApplicantSpacelabs, Inc.
Decision Date1989-11-30
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

SPACELABS MODEL 90900 is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1989-11-30 under 510(k) number K894093. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACELABS MODEL 90900?

SPACELABS MODEL 90900 is a medical device that received FDA 510(k) clearance on 1989-11-30. The listed applicant is Spacelabs, Inc.. The 510(k) number is K894093.

When did SPACELABS MODEL 90900 receive FDA 510(k) clearance?

SPACELABS MODEL 90900 received FDA 510(k) clearance on 1989-11-30, under 510(k) number K894093.

Who is the listed applicant for SPACELABS MODEL 90900?

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 90900?

The FDA product code for SPACELABS MODEL 90900 is LOS.

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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: 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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