SigmaPace 1000

FDA UDI

Class II (US FDA UDI)

by Fluke Electronics Corporation

Identity

Trade Name: SigmaPace 1000 FDA UDI
Generic Name: External defibrillator tester FDA UDI
Device Name: External Pacemaker Analyzer FDA UDI
Model / Reference: SIGMAP1K-USA120V FDA UDI
Description: External Pacemaker Analyzer FDA UDI

Identifiers

Catalog Number: 2247700 FDA UDI
Primary DI / UDI-DI: 00850540007157 FDA UDI
510(k) Number: K011729 FDA UDI
FDA Product Code: DTC FDA UDI
GMDN Term: External defibrillator tester FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3630 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

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: External defibrillator tester

SigmaPace 1000 by Fluke Electronics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Fluke Electronics Corporation

Sources (1)

FDA UDI 14b7a0b2-02dd-4045-a8f4-67589821a15b 36 fields · synced Jun 1, 2026