Simon Multichannel Recording System, Model 5500
FDA 510(k) K983572 · Healthdyne Technologies, Inc.
510(k) numberK983572
Submission
- Device name
- Simon Multichannel Recording System, Model 5500
- Applicant
- Healthdyne Technologies, Inc.
Marietta, GA, US - Received
- October 13, 1998
- Decision date
- March 19, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNR – Ventilatory Effort Recorder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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Questions and answers
When was Simon Multichannel Recording System, Model 5500 cleared by the FDA?
Simon Multichannel Recording System, Model 5500 (K983572) received a 510(k) decision of Substantially Equivalent on March 19, 1999, 157 days after the submission was received.
What is the product code of K983572?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.