FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUCLEAR STRESS TABLE (NST-1)
K Number: K800892
·
Decision May 14, 1980
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
60
Applicant Total
32
Review Days
26
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NUCLEAR STRESS TABLE (NST-1)
- K Number
- K800892
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5360
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Technicare Corp.
- Date Received
- April 18, 1980
- Decision Date
- May 14, 1980
- Product Code
- ISD
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| ISD | Exerciser, Measuring | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ISD), ordered by most recent decision date.
MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
FDA 510(k)
FDA Class 2
·Physical Medicine
REAL Immersive System
FDA 510(k)
FDA Class 2
·Physical Medicine
ActiSpec Activity Monitor
FDA 510(k)
FDA Class 2
·Physical Medicine
ERGOSELECT/GE
FDA 510(k)
FDA Class 2
·Physical Medicine
ACTITRAINER
FDA 510(k)
FDA Class 2
·Physical Medicine
ERGOSELECT 100 K/P, ERGOSELECT 200 K/P
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Technicare Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K854340 | TECHNICARE 720 HPS CT SCANNER | Nov 15, 1985 | Substantially Equivalent |
| K852089 | SATURN NUCLEAR MEDICINE COMPUTER SYSTEM | Jul 18, 1985 | Substantially Equivalent |
| K844293 | AUTO DII MULTI FREQUENCY | Feb 13, 1985 | Substantially Equivalent |
| K844247 | ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS | Jan 23, 1985 | Substantially Equivalent |
| K843716 | NUCLEAR 700 MEDICINE MECHANICAL POSIT- | Dec 17, 1984 | Substantially Equivalent |
| K842777 | AUTOFOCUS DUAL ELEMENT PROBE | Nov 29, 1984 | Substantially Equivalent |
| K841817 | TECHNICARE 248 SL & 260SL | Aug 17, 1984 | Substantially Equivalent |
| K840860 | CENTAURI CT SCANNER | May 22, 1984 | Substantially Equivalent |
| K840540 | TECHNICARE MODEL 330 | May 9, 1984 | Substantially Equivalent |
| K834486 | TECHNICARE 280 | Apr 13, 1984 | Substantially Equivalent |