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John Bunn JB02007

by GF Health Products, Inc.

John Bunn JB02007 is a pulse oximeter (FDA Class II; FDA product code DQA, Oximeter) made by GF Health Products, Inc., cleared under FDA 510(k) K063641 on 13 Jul 2007 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI M368JB020071), active as of 8 Nov 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 8 Nov 2026

Documents

510(k) K063641

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM368JB020071 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK063641 Date13 Jul 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K063641 decided 13 Jul 2007 Active
  • FDA GUDID UDI-DI M368JB020071 listed 31 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K063641
  2. Listed FDA GUDID M368JB020071

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
John Bunn
Generic name
Pulse oximeter
Model / reference
JB02007
Primary DI / UDI-DI
M368JB020071
510(k) Number
FDA product code
DQA
GMDN term
Pulse oximeter
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulse oximeter

Cleared under the same submission (K063641)

and 8 more cleared under K063641

Similar devices in this category

Other devices filed under Pulse oximeter.

Other devices from GF Health Products, Inc.

See all devices from GF Health Products, Inc. →

Properties

  • Serial number
  • Expiration date
Other properties (13, all answered No)