HEADSTRAP— 510(k) K810991
Substantially EquivalentRespironics, Inc.
FDA 510(k) clearance K810991 for HEADSTRAP, Substantially Equivalent on 1981-04-29. Applicant: Respironics, Inc.. Device class: 1.
Clearance details
- Applicant
- Respironics, Inc.
- Product code
- Code BTK
- Device class
- Class 1
- Regulation
- 21 CFR 868.5560
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monroeville, PA, US
Recent devices under product code BTK
view allMore clearances from Respironics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.