RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
FDA 510(k) clearance K955238 · decided 1996-02-06
Clearance details
- K-number
- K955238
- Device name
- RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
- Applicant
- Rusch Intl.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-14
- Decision date
- 1996-02-06
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- BSR
- Device class
- 1
- Regulation number
- 868.5790
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Jeffrey, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.