PENTAX Medical Video Esophagoscope EE17-J10— 510(k) K223072
Substantially EquivalentPentax of America, Inc.
FDA 510(k) clearance K223072 for PENTAX Medical Video Esophagoscope EE17-J10, Substantially Equivalent on 2022-12-02. Applicant: Pentax of America, Inc.. Device class: 2.
Clearance details
- Applicant
- Pentax of America, Inc.
- Product code
- Code EOX
- Device class
- Class 2
- Regulation
- 21 CFR 874.4710
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montvale, NJ, US
Recent devices under product code EOX
view allMore clearances from Pentax of America, Inc.
view all- K251256 — PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
- K251127 — PENTAX Medical Video Processor (EPK-i8020c)
- K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL)
- K241213 — PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)
- K233942 — PENTAX Medical Video Duodenoscope (ED34-i10T2s) +3 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.