HARRIS MODEL 2000
FDA 510(k) clearance K921906 · decided 1992-11-02
Clearance details
- K-number
- K921906
- Device name
- HARRIS MODEL 2000
- Applicant
- Harris Mfg. Co.
- Decision
- Substantially Equivalent
- Date received
- 1992-04-21
- Decision date
- 1992-11-02
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- LMC
- Device class
- 2
- Regulation number
- 892.2040
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Trenton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.