Compumedics Somte PSG Recording System
FDA 510(k) K072201 · Compumedics Limited
510(k) numberK072201
Submission
- Device name
- Compumedics Somte PSG Recording System
- Applicant
- Compumedics Limited
Melbourne, Victoria, AU - Received
- August 8, 2007
- Decision date
- April 14, 2008
- 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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| K252628 | CassieMNR · Traditional | Wesper, Inc. | 04/27/2026SE |
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| K250882 | Sansa HsatMNR · Traditional | Huxley Medical | 10/29/2025SE |
| K250460 | WatchPAT400 (WP400)MNR · Traditional | Itamar Medical , Ltd. | 09/05/2025SE |
| K252383 | Somfit DMNR · Special | Compumedics Limited | 08/28/2025SE |
| 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 |
More from Happy Health, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252383 | Somfit DMNR · Special | 08/28/2025SE |
| K242447 | Falcon HSTOLV · Traditional | 02/20/2025SE |
| K231546 | SomfitMNR · Traditional | 11/30/2023SE |
| K230073 | OktiGWQ · Traditional | 02/09/2023SE |
| K191785 | Orion LifeSpan MEGOLY · Traditional | 02/14/2020SE |
| K093223 | Compumedics Grael System, Models: Grael, Grael ECGGWQ · Traditional | 01/15/2010SE |
| K021176 | Compumedics Somte SystemMNR · Traditional | 01/21/2003SE |
| K003175 | Compumedics Siesta SystemOLV · Traditional | 12/27/2000SE |
Questions and answers
When was Compumedics Somte PSG Recording System cleared by the FDA?
Compumedics Somte PSG Recording System (K072201) received a 510(k) decision of Substantially Equivalent on April 14, 2008, 250 days after the submission was received.
What is the product code of K072201?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.