Model 219 Telemetry System
FDA 510(k) K895895 · Mennen Medical, Inc.
510(k) numberK895895
Submission
- Device name
- Model 219 Telemetry System
- Applicant
- Mennen Medical, Inc.
Clarence, NY, US - Received
- October 6, 1989
- Decision date
- February 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K874257 | S-10 Telephonic PolysomnographGYE · Traditional | Telediagnostic Systems, Inc. | 12/11/1987SE |
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| K860128 | Modac-Xxxx Intensive Monitoring of EEGGYE · Traditional | Grass-Telefactor Product Group | 03/27/1986SE |
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Questions and answers
When was Model 219 Telemetry System cleared by the FDA?
Model 219 Telemetry System (K895895) received a 510(k) decision of Substantially Equivalent on February 22, 1990, 139 days after the submission was received.
What is the product code of K895895?
The FDA product code is GYE – Encephalogram Telemetry System, a Class II (moderate risk) device regulated under 21 CFR 882.1855.