FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIVERSAL EXAMINATION TABLE
K Number: K842108
·
Decision Jul 17, 1984
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
25
Applicant Total
10
Review Days
49
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Basic Information
- Device Name
- UNIVERSAL EXAMINATION TABLE
- K Number
- K842108
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1540
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Engineering Dynamics Corp.
- Date Received
- May 29, 1984
- Decision Date
- July 17, 1984
- Product Code
- GZO
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| GZO | Device, Galvanic Skin Response Measurement | FDA class 2 | Neurology |
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Other Clearances by Engineering Dynamics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K871494 | UPPERCYCLE STATIONARY EXERCISE MACHINES | May 6, 1987 | Substantially Equivalent |
| K844578 | NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONA | May 14, 1985 | Substantially Equivalent |
| K834098 | STATIONARY EXERCISE BICYCLE | Dec 27, 1983 | Substantially Equivalent |
| K828313 | DIGITAL RADIOGRAPHY EXAMINATION TABLE | Oct 7, 1982 | Substantially Equivalent |
| K802254 | GENERAL ULTRASOUND EXAM. TABLE | Nov 26, 1980 | Substantially Equivalent |
| K790545 | STRESS TESTING SYSTEM, LATERAL TILTING | Jun 6, 1979 | Substantially Equivalent |
| K790544 | STRESS TESTING SYSTEM, MULTI-POSITION | Jun 5, 1979 | Substantially Equivalent |
| K790466 | U-MAT | Mar 28, 1979 | Substantially Equivalent |
| K790499 | MULTIPLE PINHOLE TOMOGRAPHIC COLLIMOTER | Mar 26, 1979 | Substantially Equivalent |