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FDA 510(k)

JM-102 JAUNDICE METER

K-Number: K972309 · 1998-09-22

ApplicantAir-Shields, Inc.
Decision Date1998-09-22
Product CodeMQM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

JM-102 JAUNDICE METER is the device name listed in this FDA 510(k) record. The listed applicant is Air-Shields, Inc.. It received FDA 510(k) clearance on 1998-09-22 under 510(k) number K972309. The device is classified under product code MQM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JM-102 JAUNDICE METER?

JM-102 JAUNDICE METER is a medical device that received FDA 510(k) clearance on 1998-09-22. The listed applicant is Air-Shields, Inc.. The 510(k) number is K972309.

When did JM-102 JAUNDICE METER receive FDA 510(k) clearance?

JM-102 JAUNDICE METER received FDA 510(k) clearance on 1998-09-22, under 510(k) number K972309.

Who is the listed applicant for JM-102 JAUNDICE METER?

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

What is the FDA product code for JM-102 JAUNDICE METER?

The FDA product code for JM-102 JAUNDICE METER is MQM.

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Other records listing Air-Shields, Inc. as applicant

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Related Devices (Code: MQM)

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.

K170882ABL90 FLEX, ABL90 FLEX PLUSRadiometer Medical ApsK110277RAPIDPOINT 405 NEONATAL BILIRUBINSiemens Healthcare DiagnosticsK073537NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265Siemens Medical Solutions DiagnosticsK042522JAUNDICE METER, MODEL JM 103Draeger Medical Infant Care, Inc.K040174BILIRUBIN ASSAY ON THE OMNI S ANALYZERRoche Diagnostics Corp.K021622HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103Hill-Rom Air-Shields

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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