HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)— 510(k) K971671
Substantially EquivalentHeidelberg Engineering
FDA 510(k) clearance K971671 for HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C), Substantially Equivalent on 1997-07-29. Applicant: Heidelberg Engineering. Device class: 2.
Clearance details
- Applicant
- Heidelberg Engineering
- Product code
- Code HLI
- Device class
- Class 2
- Regulation
- 21 CFR 886.1570
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Heidelberg, DE
Recent devices under product code HLI
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view all- K101223 — SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
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- K052935 — HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
- K042742 — HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
- K943955 — RETINA FLOWMETER
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