Datex-Ohmeda Tonometry Module M-Tono
FDA 510(k) K993656 · Datex-Ohmeda, Inc.
510(k) numberK993656
Submission
- Device name
- Datex-Ohmeda Tonometry Module M-Tono
- Applicant
- Datex-Ohmeda, Inc.
Tewksburt, MA, US - Received
- October 29, 1999
- Decision date
- March 15, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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Questions and answers
When was Datex-Ohmeda Tonometry Module M-Tono cleared by the FDA?
Datex-Ohmeda Tonometry Module M-Tono (K993656) received a 510(k) decision of Substantially Equivalent on March 15, 2000, 138 days after the submission was received.
What is the product code of K993656?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.