Dinamap MPS Portable Monitor
FDA 510(k) K971569 · Johnson & Johnson Medical, Inc.
510(k) numberK971569
Submission
- Device name
- Dinamap MPS Portable Monitor
- Applicant
- Johnson & Johnson Medical, Inc.
Tampa, FL, US - Received
- April 29, 1997
- Decision date
- September 19, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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Questions and answers
When was Dinamap MPS Portable Monitor cleared by the FDA?
Dinamap MPS Portable Monitor (K971569) received a 510(k) decision of Substantially Equivalent on September 19, 1997, 143 days after the submission was received.
What is the product code of K971569?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.