Skip to content

NatureSpirit CP-500E

by Simpro

NatureSpirit CP-500E is a Class II device made by Simpro, cleared under FDA 510(k) K172141 on 4 Apr 2018 and listed in FDA GUDID since 21 Apr 2020 (UDI-DI 00897037001113), 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) K172141

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 Number00897037001113 UDI-DI Date21 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172141 Date4 Apr 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172141 decided 4 Apr 2018 Active
  • FDA GUDID UDI-DI 00897037001113 listed 21 Apr 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172141
  2. Listed FDA GUDID 00897037001113

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
NatureSpirit
Generic name
Pulse oximeter, line-powered
Model / reference
CP-500E
Primary DI / UDI-DI
00897037001113
510(k) Number
FDA product code
DQA
GMDN term
Pulse oximeter, line-powered
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Pulse oximeter, line-powered.

Other devices from Simpro

See all devices from Simpro →

Properties

  • Over-the-counter
Other properties (14, all answered No)