LM-150HT LIGHT SOURCE
FDA 510(k) clearance K911212 · decided 1991-05-23
Clearance details
- K-number
- K911212
- Device name
- LM-150HT LIGHT SOURCE
- Applicant
- Leisegang Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-19
- Decision date
- 1991-05-23
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- ESI
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Boca Raton, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GASTROTEC (K954401) | Patrick C. Jacobssen | 1996-04-25 |
Recalls involving this device
No recalls on record reference this clearance.