HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)— 510(k) K042742
Substantially EquivalentHeidelberg Engineering
FDA 510(k) clearance K042742 for HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM), Substantially Equivalent on 2004-10-13. Applicant: Heidelberg Engineering. Device class: 2.
Clearance details
- Applicant
- Heidelberg Engineering
- Product code
- Code MXK
- Device class
- Class 2
- Regulation
- 21 CFR 886.1850
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dossenheim, DE
Recent devices under product code MXK
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- K052935 — HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
- K971671 — HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)
- K943955 — RETINA FLOWMETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.