Model IM1000 Integrated Monitor
FDA 510(k) K810731 · Gould, Inc.
510(k) numberK810731
Submission
- Device name
- Model IM1000 Integrated Monitor
- Applicant
- Gould, Inc.
Walker, MI, US - Received
- March 17, 1981
- Decision date
- March 27, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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Questions and answers
When was Model IM1000 Integrated Monitor cleared by the FDA?
Model IM1000 Integrated Monitor (K810731) received a 510(k) decision of Substantially Equivalent on March 27, 1981, 10 days after the submission was received.
What is the product code of K810731?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.