FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 1309 AUDIO MONITOR
K Number: K790664
·
Decision Apr 23, 1979
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
74
Applicant Total
19
Review Days
17
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
- MODEL 1309 AUDIO MONITOR
- K Number
- K790664
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Life-Tech Instruments, Inc.
- Date Received
- April 6, 1979
- Decision Date
- April 23, 1979
- Product Code
- IKN
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| IKN | Electromyograph, Diagnostic | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IKN), ordered by most recent decision date.
Natus VikingQuest
FDA 510(k)
FDA Class 2
·Physical Medicine
ViMove2
FDA 510(k)
FDA Class 2
·Physical Medicine
Cadwell Sierra Summit, Cadwell Sierra Ascent
FDA 510(k)
FDA Class 2
·Physical Medicine
ViMove
FDA 510(k)
FDA Class 2
·Physical Medicine
VIMOVE
FDA 510(k)
FDA Class 2
·Physical Medicine
PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Life-Tech Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K812177 | LIFE-TECH #1857 PRESSURE/POLOT MODULE | Sep 9, 1981 | Substantially Equivalent |
| K812179 | LIFE-TECH #1753 BIOFEEDBACK TRAINER | Aug 25, 1981 | Substantially Equivalent |
| K812180 | LIFE-TECH #5102 VISULAB | Aug 21, 1981 | Substantially Equivalent |
| K812178 | LIFE-TECH #'S 1106/1156 UROLABS | Aug 13, 1981 | Substantially Equivalent |
| K800112 | AMBLYOPIA TRAINER | Mar 10, 1980 | Substantially Equivalent |
| K790663 | MODEL 1750 STANDING URINAL | Apr 24, 1979 | Substantially Equivalent |
| K781476 | MULAR GOLD LEAF ELECTRODE MODEL 7501 | Nov 15, 1978 | Substantially Equivalent |
| K781461 | MODEL 7320 VISUAL STIMULATOR | Nov 8, 1978 | Substantially Equivalent |
| K781475 | ELECTRODE IMPEDANCE TESTER-MODEL 500 | Sep 7, 1978 | Substantially Equivalent |
| K781474 | PREAMPLIFIER MODELS 8101PI & 8102PI | Sep 7, 1978 | Substantially Equivalent |