John Bunn JB02020
John Bunn JB02020 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 5 May 2020 (UDI-DI M368JB020201), active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM368JB020201 | Date5 May 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK063641 | Date13 Jul 2007 | StatusActive |
Official records
- FDA 510(k) database K063641
Across registries
- FDA 510(k) K063641 decided 13 Jul 2007 Active
- FDA GUDID UDI-DI M368JB020201 listed 5 May 2020 Listed
Timeline
- Cleared FDA 510(k) K063641
- Listed FDA GUDID M368JB020201
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- John Bunn
- Generic name
- Pulse oximeter
- Model / Ref / Catalog
- JB02020
- Primary DI / UDI-DI
- M368JB020201
- 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
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