FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOTHORACIC RULER
K Number: K902378
·
Decision Jun 14, 1990
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
6
Review Days
16
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Basic Information
- Device Name
- CARDIOTHORACIC RULER
- K Number
- K902378
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Devcom, Inc.
- Date Received
- May 29, 1990
- Decision Date
- June 14, 1990
- Product Code
- KPR
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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Other Clearances by Devcom, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874233 | BLOOD PRESSURE SLEEVE W/TUBING | Mar 22, 1988 | Substantially Equivalent |
| K863313 | GRIP STRENGTH DEVICE (GSD) | Sep 9, 1986 | Substantially Equivalent |
| K861264 | JOINT MEASUREMENT INDICATOR | Apr 15, 1986 | Substantially Equivalent |
| K861043 | SPINAL EXCURSION METER | Mar 28, 1986 | Substantially Equivalent |
| K850021 | ELECTROCARDIOGRAPH-ECG CALIPER | Feb 8, 1985 | Substantially Equivalent |