RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE— 510(k) K955238
Substantially EquivalentRusch Intl.
FDA 510(k) clearance K955238 for RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE, Substantially Equivalent on 1996-02-06. Applicant: Rusch Intl.. Device class: 1.
Clearance details
- Applicant
- Rusch Intl.
- Product code
- Code BSR
- Device class
- Class 1
- Regulation
- 21 CFR 868.5790
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jeffrey, NH, US
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- K943104 — MOLLOY INTUBATING STYLETTE
- K953677 — LIGHTED FLEXGUIDE (MODIFICATION)
More clearances from Rusch Intl.
view allAdverse events under product code BSR
product code BSR- Death
- 2
- Other
- 1
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.