Clevemed 501-0261-1
by S. L. P. Scientific Laboratory Products Ltd
Clevemed 501-0261-1 is a Class II device made by S. L. P. Scientific Laboratory Products Ltd, cleared under FDA 510(k) K042253 on 6 Oct 2004 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 07290013817648), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290013817648 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK042253 | Date6 Oct 2004 | StatusActive |
Official records
- AccessGUDID record 07290013817648
- FDA 510(k) database K042253
Across registries
- FDA 510(k) K042253 decided 6 Oct 2004 Active
- FDA GUDID UDI-DI 07290013817648 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K042253
- Listed FDA GUDID 07290013817648
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Clevemed
- Generic name
- Electrode/transducer strap, reusable
- Model / reference
- 501-0261-1
- Primary DI / UDI-DI
- 07290013817648
- 510(k) Number
- FDA product code
- MNR
- GMDN term
- Electrode/transducer strap, reusable
- Device class
- Class II
- Regulation number
- 868.2375
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MNR (Ventilatory Effort Recorder).
- WATCH PAT 100S by ITAMAR MEDICAL LTD
- APNEA RISK EVALUATION SYSTEM (ARES) by Advanced Brain Monitoring, Inc.
- STAR 65 F3-86-390-1000-21 by Skanray Technologies
- APNEALINK by Resmed Germany, Inc.
- DEVILBISS SLEEP RECORDER MODEL # RM60 by Sunrise Medical Hhg, Inc.
- ALPHAMED GEMINI SENSOR, SNORING SENSOR by Alphamed, Inc.
- AcuPebble Ox (200) by Acurable Limited
- MORPHEUS OX by Widemed, Ltd.
- DIGI-SNAP by Snap Laboratories, LLC
- APLAB, MODEL 801D0030 by Sector Medical Corp.
Other devices from S. L. P. Scientific Laboratory Products Ltd
See all devices from S. L. P. Scientific Laboratory Products Ltd →