Horizon 9000/HIS Option Amplifier
FDA 510(k) K914381 · Mennen Medical, Inc.
510(k) numberK914381
Submission
- Device name
- Horizon 9000/HIS Option Amplifier
- Applicant
- Mennen Medical, Inc.
Clarence, NY, US - Received
- October 3, 1991
- Decision date
- January 28, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRR – Amplifier And Signal Conditioner, Biopotential
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2050
- Specialty
- Cardiovascular
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Questions and answers
When was Horizon 9000/HIS Option Amplifier cleared by the FDA?
Horizon 9000/HIS Option Amplifier (K914381) received a 510(k) decision of Substantially Equivalent on January 28, 1992, 117 days after the submission was received.
What is the product code of K914381?
The FDA product code is DRR – Amplifier And Signal Conditioner, Biopotential, a Class II (moderate risk) device regulated under 21 CFR 870.2050.