The following data is part of a premarket notification filed by Heidelberg Engineering with the FDA for Spectralis Hra+oct, Spectralis Fa_oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis Fa.
Device ID | K101223 |
510k Number | K101223 |
Device Name: | SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA |
Classification | Tomography, Optical Coherence |
Applicant | HEIDELBERG ENGINEERING 1220 NINETEENTH ST, NW SUITE 300 Washington, DC 20036 |
Contact | Diane Mandell-horwitz |
Correspondent | Diane Mandell-horwitz HEIDELBERG ENGINEERING 1220 NINETEENTH ST, NW SUITE 300 Washington, DC 20036 |
Product Code | OBO |
CFR Regulation Number | 886.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-05-03 |
Decision Date | 2010-10-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04059237000280 | K101223 | 000 |
04059237000075 | K101223 | 000 |
04059237000051 | K101223 | 000 |
04059237000044 | K101223 | 000 |
04059237000037 | K101223 | 000 |
04059237000020 | K101223 | 000 |
04059237000013 | K101223 | 000 |