The following data is part of a premarket notification filed by Heidelberg Engineering Gmbh with the FDA for Spectralis Anterior Segment Module (spectralis Asm).
Device ID | K113129 |
510k Number | K113129 |
Device Name: | SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) |
Classification | Tomography, Optical Coherence |
Applicant | HEIDELBERG ENGINEERING GMBH TIERGARTENSTRASSE 15 Heidelberg, DE 69121 |
Contact | Gerhard Zinser |
Product Code | OBO |
CFR Regulation Number | 886.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2011-10-24 |
Decision Date | 2011-11-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04059237000112 | K113129 | 000 |