Datex-Ohmeda S/5 Device Interfacing Solution, N-DISXXXX..01 with N-DISVENT..02
FDA 510(k) K070421 · GE Healthcare
510(k) numberK070421
Submission
- Device name
- Datex-Ohmeda S/5 Device Interfacing Solution, N-DISXXXX..01 with N-DISVENT..02
- Applicant
- GE Healthcare
Needham, MA, US - Received
- February 13, 2007
- Decision date
- March 13, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Datex-Ohmeda S/5 Device Interfacing Solution, N-DISXXXX..01 with N-DISVENT..02 cleared by the FDA?
Datex-Ohmeda S/5 Device Interfacing Solution, N-DISXXXX..01 with N-DISVENT..02 (K070421) received a 510(k) decision of Substantially Equivalent on March 13, 2007, 28 days after the submission was received.
What is the product code of K070421?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.