510(k) K134026
- Device
- ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT
- Applicant
- OLYMPUS MEDICAL SYSTEMS CORP.
- 510(k) number
- K134026
- Product code
- PGU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-03-07
- Date received
- 2013-12-30
- Regulation
- 876.1500
- Classification name
- Spatial Imaging For Display Of Endoscope Position
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAPHNEY GERMAIN-KOLAWOLE
- Address
- 3500 Corporate Pkwy. P.O. Box 610 Center Valley PA US 18034 18034
FDA Registration Numbers#
- 9610595
- 8010047
- 3002808148
Source Documents#
Legacy Summary#
summary
FDA Review#
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