Tomey PE-300 Portable Erg

FDA 510(k) K921815 · Tomey Corporation USA

Substantially Equivalent

510(k) numberK921815

Submission

Device name
Tomey PE-300 Portable Erg
Applicant
Tomey Corporation USA
Cambridge, MA, US
Received
April 15, 1992
Decision date
July 15, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HLT – Preamplifier, Ac-Powered, Ophthalmic
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1640
Specialty
Ophthalmic

Other 510(k)s with product code HLT

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K781543OrbiographHLT · Traditional Sonometrics Systems, Inc.10/24/1978SE

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Questions and answers

When was Tomey PE-300 Portable Erg cleared by the FDA?

Tomey PE-300 Portable Erg (K921815) received a 510(k) decision of Substantially Equivalent on July 15, 1992, 91 days after the submission was received.

What is the product code of K921815?

The FDA product code is HLT – Preamplifier, Ac-Powered, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.1640.