510(k) K021138
K021138 is an FDA 510(k) premarket notification submitted by Erich Jaeger GmbH for the device "SLEEPSCREEN/APNOESCREEN CARDIO". The FDA issued a decision of Substantially Equivalent on February 12, 2003. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Erich Jaeger GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2003
- Date Received
- April 9, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilatory Effort Recorder
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type