Advanced Nibp Module
FDA 510(k) K982641 · Johnson & Johnson Medical, Inc.
510(k) numberK982641
Submission
- Device name
- Advanced Nibp Module
- Applicant
- Johnson & Johnson Medical, Inc.
Tampa, FL, US - Received
- July 29, 1998
- Decision date
- March 29, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXN – System, Measurement, Blood-Pressure, Non-Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1130
- Specialty
- Cardiovascular
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Questions and answers
When was Advanced Nibp Module cleared by the FDA?
Advanced Nibp Module (K982641) received a 510(k) decision of Substantially Equivalent on March 29, 1999, 243 days after the submission was received.
What is the product code of K982641?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.