FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
K Number: K042742
·
Decision Oct 13, 2004
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
22
Applicant Total
9
Review Days
9
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Basic Information
- Device Name
- HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
- K Number
- K042742
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heidelberg Engineering
- Date Received
- October 4, 2004
- Decision Date
- October 13, 2004
- Product Code
- MXK
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MXK | Device, Analysis, Anterior Segment | FDA class 2 | Ophthalmic |
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Other Clearances by Heidelberg Engineering
| K Number | Device Name | ||
|---|---|---|---|
| K101223 | SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA | Oct 1, 2010 | Substantially Equivalent |
| K063191 | HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT | Oct 31, 2006 | Substantially Equivalent |
| K052935 | HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) | Jan 13, 2006 | Substantially Equivalent |
| K971671 | HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) | Jul 29, 1997 | Substantially Equivalent |
| K943956 | RETINA TOMOGRAPH AND FLOWMETER | Nov 14, 1994 | Substantially Equivalent |
| K943955 | RETINA FLOWMETER | Nov 14, 1994 | Substantially Equivalent |
| K944261 | RETINA ANGIOGRAPH | Nov 14, 1994 | Substantially Equivalent |
| K912891 | HEIDELBERG RETINA TOMOGRAPH | Sep 27, 1991 | Substantially Equivalent |