iExaminer System with Panoptic Plus— 510(k) K223381
Substantially EquivalentWelch Allyn, Inc.
FDA 510(k) clearance K223381 for iExaminer System with Panoptic Plus, Substantially Equivalent on 2023-03-15. Applicant: Welch Allyn, Inc.. Device class: 2.
Clearance details
- Applicant
- Welch Allyn, Inc.
- Product code
- Code HKI
- Device class
- Class 2
- Regulation
- 21 CFR 886.1120
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skaneateles Falls, NY, US
Recent devices under product code HKI
view allMore clearances from Welch Allyn, Inc.
view all- K243598 — Welch Allyn Connex® 360 (Multiple)
- K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)
- K212473 — Welch Allyn Connex Central Station
- K191013 — Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
- K181016 — Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
Data sourced from openFDA. This site is unofficial and independent of the FDA.