Tru-View Multi-Channel Display
FDA 510(k) K912008 · General Devices
510(k) numberK912008
Submission
- Device name
- Tru-View Multi-Channel Display
- Applicant
- General Devices
Bogota, NJ, US - Received
- May 6, 1991
- Decision date
- October 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
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Questions and answers
When was Tru-View Multi-Channel Display cleared by the FDA?
Tru-View Multi-Channel Display (K912008) received a 510(k) decision of Substantially Equivalent on October 9, 1991, 156 days after the submission was received.
What is the product code of K912008?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.