IOBClass II
Lamp, Infrared, Non Heating
21 CFR 890.5500 / Physical Medicine
IOB is the FDA product code for Lamp, Infrared, Non Heating, a class II device type, regulated under 21 CFR 890.5500. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- IOB
- Device name
- Lamp, Infrared, Non Heating
- Regulation
- 21 CFR 890.5500
- Device class
- Class II
- Review panel
- Physical Medicine
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 6
- Ingested recalls
- 0
Clearances, product code IOB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1984 | 1 |
| 1991 | 2 |
Applicants with the most clearances
Product code IOB| Applicant | Clearances |
|---|---|
| Dermatron Corp. | 1 |
| Mt. Hood Mfr., Inc. | 1 |
| North American Philips Corp. | 1 |
| Osram GmbH | 1 |
| Solitec GmbH | 1 |
| Ultralite | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code IOB.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.