Skip to content

Eview PV220

by Zhuhai Pusen Medical Technology Co, Ltd

Eview PV220 is a Class II device made by Zhuhai Pusen Medical Technology Co, Ltd, cleared under FDA 510(k) K190648 on 29 Mar 2019 and listed in FDA GUDID since 22 Jan 2026 (UDI-DI 06971176282399), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K190648

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06971176282399 UDI-DI Date22 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190648 Date29 Mar 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190648 decided 29 Mar 2019 Active
  • FDA GUDID UDI-DI 06971176282399 listed 22 Jan 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190648
  2. Listed FDA GUDID 06971176282399

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Eview
Generic name
Endoscopic video image processing unit
Model / reference
PV220
Primary DI / UDI-DI
06971176282399
510(k) Number
FDA product code
FET
GMDN term
Endoscopic video image processing unit
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Cleared under the same submission (K190648)

Other devices from Zhuhai Pusen Medical Technology Co, Ltd

See all devices from Zhuhai Pusen Medical Technology Co, Ltd →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)