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FDA 510(k)

EIM-107 PREP-CHECK

K-Number: K993202 · 1999-12-17

ApplicantGeneral Devices
Decision Date1999-12-17
Product CodeGZO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EIM-107 PREP-CHECK is the device name listed in this FDA 510(k) record. The listed applicant is General Devices. It received FDA 510(k) clearance on 1999-12-17 under 510(k) number K993202. The device is classified under product code GZO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EIM-107 PREP-CHECK?

EIM-107 PREP-CHECK is a medical device that received FDA 510(k) clearance on 1999-12-17. The listed applicant is General Devices. The 510(k) number is K993202.

When did EIM-107 PREP-CHECK receive FDA 510(k) clearance?

EIM-107 PREP-CHECK received FDA 510(k) clearance on 1999-12-17, under 510(k) number K993202.

Who is the listed applicant for EIM-107 PREP-CHECK?

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

What is the FDA product code for EIM-107 PREP-CHECK?

The FDA product code for EIM-107 PREP-CHECK is GZO.

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Other records listing General Devices 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.

K013533EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)K002089ROSETTA-LT/ROSETTA-RXK940009GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300K935839GEMSCOM SERIES 5000,K921929GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)K914889GEMSCOM SERIES 3000

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Related Devices (Code: GZO)

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.

K131568SUDO PATHLd Technology, LLCK111308ZYTO HAND CRADLEZyto Technologies, Inc.K102166ELECTRO INTERSTITIAL SCANLd Technology, LLCK100233SUDOSCANImpeto MedicalK053004MSAS-VANTAGEBiomeridian, Int.K032935EPI-SCAN, MODEL P 100Edx Epi-Scan, 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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