SLEEPSCREEN/APNOESCREEN CARDIO
FDA 510(k) clearance K021138 · decided 2003-02-12
Clearance details
- K-number
- K021138
- Device name
- SLEEPSCREEN/APNOESCREEN CARDIO
- Applicant
- Erich Jaeger GmbH
- Decision
- Substantially Equivalent
- Date received
- 2002-04-09
- Decision date
- 2003-02-12
- Days to decision
- 309 days
- Clearance type
- Traditional
- Product code
- MNR
- Device class
- 2
- Regulation number
- 868.2375
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Yorba Linda, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.