The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Cmos Video Rhino-laryngoscope System Model 11101cm.
| Device ID | K103467 |
| 510k Number | K103467 |
| Device Name: | CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Contact | Shiven Gandhi |
| Correspondent | Shiven Gandhi KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-24 |
| Decision Date | 2012-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551260128 | K103467 | 000 |