The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Aida Compact Ii System.
Device ID | K052159 |
510k Number | K052159 |
Device Name: | AIDA COMPACT II SYSTEM |
Classification | System, Image Processing, Radiological |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Contact | Paul Lee |
Correspondent | Paul Lee KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-08-09 |
Decision Date | 2005-09-07 |