KARL STORZ AUTOFLUORESCENCE SYSTEM
FDA premarket approval P020008/S002 · decided 2009-12-23
Approval details
- PMA number
- P020008
- Supplement
- S002
- Supplement type
- Real-Time Process
- Trade name
- KARL STORZ AUTOFLUORESCENCE SYSTEM
- Generic name
- SYSTEM, IMAGING, FLUORESCENCE
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 2009-10-22
- Decision date
- 2009-12-23
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- MRK
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Culver City, CA
- Statement
- APPROVAL FOR REPLACEMENT OF THE KARL STORZ CAMERA CONTROL UNIT (CCU), TRICAM SL (ANALOG PROCESSING) WITH THE TRICAM SL II (DIGITAL SIGNAL PROCESSING).
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