Accutorr Plus Non Invasive Blood Pressure Monitor (0998-00-0117-XX)
FDA 510(k) K970061 · Datascope Corp.
510(k) numberK970061
Submission
- Device name
- Accutorr Plus Non Invasive Blood Pressure Monitor (0998-00-0117-XX)
- Applicant
- Datascope Corp.
Paramus, NJ, US - Received
- January 7, 1997
- Decision date
- September 25, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DQA – Oximeter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
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Questions and answers
When was Accutorr Plus Non Invasive Blood Pressure Monitor (0998-00-0117-XX) cleared by the FDA?
Accutorr Plus Non Invasive Blood Pressure Monitor (0998-00-0117-XX) (K970061) received a 510(k) decision of Substantially Equivalent on September 25, 1997, 261 days after the submission was received.
What is the product code of K970061?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.