Single Measurement Calbox

FDA UDI

Class II (US FDA UDI)

by DGH Technology, Inc.

Identity

Trade Name: Single Measurement Calbox FDA UDI
Generic Name: Ultrasound pachymeter FDA UDI
Device Name: The pachymeter calbox is an accessory that connects to a pachymeter and creates a single precise, predetermined electronic pulse. The pachymeter measures the pulse, and the operator verifies that the measurement value is within an acceptable range. FDA UDI
Model / Reference: SM Calbox FDA UDI
Description: The pachymeter calbox is an accessory that connects to a pachymeter and creates a single precise, predetermined electronic pulse. The pachymeter measures the pulse, and the operator verifies that the measurement value is within an acceptable range. FDA UDI

Identifiers

Primary DI / UDI-DI: 00857377006308 FDA UDI
510(k) Number: K920906 FDA UDI
FDA Product Code: IYO FDA UDI
GMDN Term: Ultrasound pachymeter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 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

Yes

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: Ultrasound pachymeter

Single Measurement Calbox by DGH Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound pachymeter.

Gilras — U.S. OPHTHALMIC, L.L.C. · Class II
Pachymetry probe — Nidek, Inc. · Class II
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Accupach VI — ACCUTOME, INC. · Class II
iPac® Pachymeter — REICHERT INC. · Class II
Pachpen- VET — ACCUTOME, INC. · Class II
POCKET — QUANTEL MEDICAL · Class II
Pachymetry probe (45° fixed type) — Nidek, Inc. · Class II

Cleared under the same submission

K920906 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: DGH Technology, Inc.

Sources (1)

FDA UDI 8d291a12-81a6-4694-8cd4-0825eb1fe73a 34 fields · synced Jun 15, 2026