Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM)

FDA 510(k) K042742 · Heidelberg Engineering

Substantially Equivalent

510(k) numberK042742

Submission

Device name
Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM)
Applicant
Heidelberg Engineering
Dossenheim, DE
Received
October 4, 2004
Decision date
October 13, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
MXK – Device, Analysis, Anterior Segment
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1850
Specialty
Ophthalmic

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Questions and answers

When was Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM) cleared by the FDA?

Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM) (K042742) received a 510(k) decision of Substantially Equivalent on October 13, 2004, 9 days after the submission was received.

What is the product code of K042742?

The FDA product code is MXK – Device, Analysis, Anterior Segment, a Class II (moderate risk) device regulated under 21 CFR 886.1850.