FDA-Device2017-07-26Class II
9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
Pentax of America Inc
Hazard
Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Sold states
Worldwide Distribution - US Nationwide
Affected count
241 units in total
Manufactured in
3 Paragon Dr, N/A, Montvale, NJ, United States
Products
9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2745-2017Don't want to check this manually?
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