Fltr

FDA UDI

Class II (US FDA UDI)

by Shenzhen Pacom Medical Instruments Co., Ltd.

Identity

Trade Name: FLTR FDA UDI
Generic Name: Infrared patient thermometer, ear/skin FDA UDI
Device Name: Model: PC801; Brand: FLTR; One inner packing box contains 4 device; One outer packing box contains 5 inner packing boxes. Per outer packing box can pack 20 devices. FDA UDI
Model / Reference: PC801 FDA UDI
Description: Model: PC801; Brand: FLTR; One inner packing box contains 4 device; One outer packing box contains 5 inner packing boxes. Per outer packing box can pack 20 devices. FDA UDI

Identifiers

Primary DI / UDI-DI: 00840061480119 FDA UDI
510(k) Number: K190717 FDA UDI
FDA Product Code: FLL FDA UDI
GMDN Term: Infrared patient thermometer, ear/skin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Infrared patient thermometer, ear/skin

Fltr by Shenzhen Pacom Medical Instruments Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infrared patient thermometer, ear/skin.

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Infrared Thermometer — Shenzhen Jumper Medical Equipment Co., Ltd. · Class II
MOBI — MOBI TECHNOLOGIES, INC. · Class II
CONAIR CORPORATION — CONAIR LLC. · Class II
AlphaMed — Shenzhen Urion Technology Co., Ltd. · Class II
Dr.Protekt Safety First — Krisco Sales LLC · Class II

Cleared under the same submission

K190717 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Shenzhen Pacom Medical Instruments Co., Ltd.

Sources (1)

FDA UDI 01ad18c9-5f12-43b4-9da5-28a85c78bdd5 34 fields · synced Jun 6, 2026