SALTER LABS MODEL #1015— 510(k) K903539
Substantially EquivalentSalter Labs
FDA 510(k) clearance K903539 for SALTER LABS MODEL #1015, Substantially Equivalent on 1990-12-17. Applicant: Salter Labs. Device class: 1.
Clearance details
- Applicant
- Salter Labs
- Product code
- Code CBH
- Device class
- Class 1
- Regulation
- 21 CFR 868.5770
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arvin, CA, US
Recent devices under product code CBH
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Adverse events under product code CBH
product code CBH- Death
- 7
- Total
- 7
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.