RETINA FLOWMETER— 510(k) K943955
Substantially EquivalentHeidelberg Engineering
FDA 510(k) clearance K943955 for RETINA FLOWMETER, Substantially Equivalent on 1994-11-14. 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
- D06900 Heidelberg,Germany, DE
Recent devices under product code HLI
view allMore clearances from Heidelberg Engineering
view all- K101223 — SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
- K063191 — HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT
- K052935 — HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
- K042742 — HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
- K971671 — HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)
Data sourced from openFDA. This site is unofficial and independent of the FDA.