Sandman Pocket
FDA 510(k) K061996 · Eb Neuro S.P.A.
510(k) numberK061996
Submission
- Device name
- Sandman Pocket
- Applicant
- Eb Neuro S.P.A.
Carmel, IN, US - Received
- July 14, 2006
- Decision date
- October 3, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Sandman Pocket cleared by the FDA?
Sandman Pocket (K061996) received a 510(k) decision of Substantially Equivalent on October 3, 2006, 81 days after the submission was received.
What is the product code of K061996?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.