PalmScan AP2000

FDA UDI

Class II (US FDA UDI)

by Micro Medical Devices, Inc.

Identity

Trade Name: PalmScan AP2000 FDA UDI
Generic Name: Ophthalmic ultrasound imaging transducer FDA UDI
Device Name: A 2000 portable A-scan biometer; AP 2000 Portable Ascan / Pachymeter; P 2000 Portable Pachymeter Classification Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC FDA UDI
Model / Reference: AP2000 FDA UDI
Description: A 2000 portable A-scan biometer; AP 2000 Portable Ascan / Pachymeter; P 2000 Portable Pachymeter Classification Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC FDA UDI

Identifiers

Catalog Number: 900-0006-02-1 FDA UDI
Primary DI / UDI-DI: 00853569007030 FDA UDI
510(k) Number: K043287 FDA UDI
FDA Product Code: IYO FDA UDI
GMDN Term: Ophthalmic ultrasound imaging transducer 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

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

Yes

FDA UDI

Category: Ophthalmic ultrasound imaging transducer

PalmScan AP2000 by Micro Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Ophthalmic ultrasound imaging transducer.

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LIN 50MHz Probe — QUANTEL MEDICAL · Class II
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Cleared under the same submission

K043287 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: Micro Medical Devices, Inc.

Sources (1)

FDA UDI 8bb34b4e-3690-478a-a9d4-ff7fa2e16db9 37 fields · synced May 30, 2026