CONTOUROGRAPH M-500
FDA 510(k) clearance K800591 · decided 1980-04-02
Clearance details
- K-number
- K800591
- Device name
- CONTOUROGRAPH M-500
- Applicant
- Bio-Tek Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-03-17
- Decision date
- 1980-04-02
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- LDK
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.