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FDA 510(k)

SPACE LABS MODEL 90560

K-Number: K923788 · 1993-12-06

ApplicantSpacelabs, Inc.
Decision Date1993-12-06
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

SPACE LABS MODEL 90560 is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1993-12-06 under 510(k) number K923788. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACE LABS MODEL 90560?

SPACE LABS MODEL 90560 is a medical device that received FDA 510(k) clearance on 1993-12-06. The listed applicant is Spacelabs, Inc.. The 510(k) number is K923788.

When did SPACE LABS MODEL 90560 receive FDA 510(k) clearance?

SPACE LABS MODEL 90560 received FDA 510(k) clearance on 1993-12-06, under 510(k) number K923788.

Who is the listed applicant for SPACE LABS MODEL 90560?

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 SPACE LABS MODEL 90560?

The FDA product code for SPACE LABS MODEL 90560 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 MODULEK912742ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBEK913038SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION

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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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