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FDA 510(k)

MINI-LOGGER SERIES 2000

K-Number: K991045 · 1999-09-21

ApplicantMini-Mitter Co., Inc.
Decision Date1999-09-21
Product CodeGWK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MINI-LOGGER SERIES 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Mini-Mitter Co., Inc.. It received FDA 510(k) clearance on 1999-09-21 under 510(k) number K991045. The device is classified under product code GWK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINI-LOGGER SERIES 2000?

MINI-LOGGER SERIES 2000 is a medical device that received FDA 510(k) clearance on 1999-09-21. The listed applicant is Mini-Mitter Co., Inc.. The 510(k) number is K991045.

When did MINI-LOGGER SERIES 2000 receive FDA 510(k) clearance?

MINI-LOGGER SERIES 2000 received FDA 510(k) clearance on 1999-09-21, under 510(k) number K991045.

Who is the listed applicant for MINI-LOGGER SERIES 2000?

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

What is the FDA product code for MINI-LOGGER SERIES 2000?

The FDA product code for MINI-LOGGER SERIES 2000 is GWK.

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Other records listing Mini-Mitter Co., 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.

K033534VITALSENSEK011430ACTIWARE-PLMSK991033ACTIWATCH-SCOREK983533ACTIWATCH

Related Devices (Code: GWK)

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.

K060919ACTICALRespironics, Inc.K061870VITALSENSE XHRRespironics, Inc.K052489ACTIHEARTRespironics, Inc.K905594NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300Nihon Kohden America, Inc.K904328VISTA POLYSOMNOGRAPHY COMPUTER SYSTEMTelediagnostic Systems, Inc.K896164ASC-954 INTEGRATOR AMPLIFIERAstro-Med, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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