BARO-GRAF 24— 510(k) K881297
Substantially EquivalentInstromedix, Inc.
FDA 510(k) clearance K881297 for BARO-GRAF 24, Substantially Equivalent on 1988-09-16. Applicant: Instromedix, Inc.. Device class: 2.
Clearance details
- Applicant
- Instromedix, Inc.
- Product code
- Code DRS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2850
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hillsboro, OR, US
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More clearances from Instromedix, Inc.
view allAdverse events under product code DRS
product code DRS- Death
- 8
- Malfunction
- 776
- Total
- 784
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.