Model 1309 Audio Monitor
FDA 510(k) K790664 · Life-Tech Instruments, Inc.
510(k) numberK790664
Submission
- Device name
- Model 1309 Audio Monitor
- Applicant
- Life-Tech Instruments, Inc.
Mchenry, IL, US - Received
- April 6, 1979
- Decision date
- April 23, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IKN – Electromyograph, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Specialty
- Physical Medicine
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| K800112 | Amblyopia TrainerHPL · Traditional | 03/10/1980SE |
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| K781476 | Mular Gold Leaf Electrode Model 7501HLZ · Traditional | 11/15/1978SE |
| K781461 | Model 7320 Visual StimulatorGWE · Traditional | 11/08/1978SE |
| K781475 | Electrode Impedance Tester-Model 500GYA · Traditional | 09/07/1978SE |
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Questions and answers
When was Model 1309 Audio Monitor cleared by the FDA?
Model 1309 Audio Monitor (K790664) received a 510(k) decision of Substantially Equivalent on April 23, 1979, 17 days after the submission was received.
What is the product code of K790664?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.