FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CONTOUROGRAPH M-500
K Number: K800591
·
Decision Apr 2, 1980
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
7
Applicant Total
37
Review Days
16
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Basic Information
- Device Name
- CONTOUROGRAPH M-500
- K Number
- K800591
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Bio-Tek Instruments, Inc.
- Date Received
- March 17, 1980
- Decision Date
- April 2, 1980
- Product Code
- LDK
- Advisory Committee
- Unknown
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LDK | Device, Sensing, Optical Contour | FDA unclassified | Unknown |
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Other Clearances by Bio-Tek Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K954391 | MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER | Nov 17, 1995 | Substantially Equivalent |
| K953710 | ELX808 AUTOMATED MICROPLATE READERS | Oct 25, 1995 | Substantially Equivalent |
| K953572 | ELX800UV | Oct 19, 1995 | Substantially Equivalent |
| K950104 | ELX800 AND EL800 AUTOMATED MICROPLATE READERS | Mar 21, 1995 | Substantially Equivalent |
| K942923 | CERES 900C & CERES UV900C | Feb 6, 1995 | Substantially Equivalent |
| K944257 | LIONHEART 3 MULTI-PARAMETER SIMULATOR | Sep 21, 1994 | Substantially Equivalent |
| K933519 | INDEX SPO2 SIMULATOR | Sep 1, 1994 | Substantially Equivalent |