Devilbiss Sleep Recorder Model # RM60
FDA 510(k) K012437 · Sunrise Medical Hhg, Inc.
510(k) numberK012437
Submission
- Device name
- Devilbiss Sleep Recorder Model # RM60
- Applicant
- Sunrise Medical Hhg, Inc.
Somerset, PA, US - Received
- July 31, 2001
- Decision date
- July 16, 2002
- 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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| K243220 | Onera STS 2 (ONERA STS 2)MNR · Traditional | Onera B.V. | 07/03/2025SE |
| K242224 | Happy Health Home Sleep TestMNR · Traditional | Happy Health, Inc. | 06/18/2025SE |
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| K011229 | Devilbiss 9000 Series CPAP, Model 9001BZD · Special | 07/11/2001SE |
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| K991722 | Devilbiss 5 Liter Oxygen ConcentratorCAW · Traditional | 11/03/1999SE |
| K982304 | Devilbiss Suction UnitJCX · Traditional | 09/25/1998SE |
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Questions and answers
When was Devilbiss Sleep Recorder Model # RM60 cleared by the FDA?
Devilbiss Sleep Recorder Model # RM60 (K012437) received a 510(k) decision of Substantially Equivalent on July 16, 2002, 350 days after the submission was received.
What is the product code of K012437?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.