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FDA 510(k)

4002 INFANT SCALE FOR INCUBATORS AND WARMERS

K-Number: K935609 · 1994-07-01

ApplicantScale-Tronix, Inc.
Decision Date1994-07-01
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

4002 INFANT SCALE FOR INCUBATORS AND WARMERS is the device name listed in this FDA 510(k) record. The listed applicant is Scale-Tronix, Inc.. It received FDA 510(k) clearance on 1994-07-01 under 510(k) number K935609. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4002 INFANT SCALE FOR INCUBATORS AND WARMERS?

4002 INFANT SCALE FOR INCUBATORS AND WARMERS is a medical device that received FDA 510(k) clearance on 1994-07-01. The listed applicant is Scale-Tronix, Inc.. The 510(k) number is K935609.

When did 4002 INFANT SCALE FOR INCUBATORS AND WARMERS receive FDA 510(k) clearance?

4002 INFANT SCALE FOR INCUBATORS AND WARMERS received FDA 510(k) clearance on 1994-07-01, under 510(k) number K935609.

Who is the listed applicant for 4002 INFANT SCALE FOR INCUBATORS AND WARMERS?

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

What is the FDA product code for 4002 INFANT SCALE FOR INCUBATORS AND WARMERS?

The FDA product code for 4002 INFANT SCALE FOR INCUBATORS AND WARMERS is FMT.

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Other records listing Scale-Tronix, 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.

K912662SCALE-TRONIX PLATFORM SCALEK904286SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIEDK902260SCALE-TRONIX INCUBATOR SCALE MODEL:4050

Related Devices (Code: FMT)

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.

K243606Babyroo TN300Draeger Medical Systems, Inc.K230278Babyroo TN300Draeger Medical Systems, Inc.K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc.K201628Panda iRes Warmer, Giraffe WarmerGE HealthcareK200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface CableDeroyal Industries, Inc.K191425Hydro-Temp Neonatal Skin Temperature Probe CoverDeroyal Industries, 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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