CT-1600 DIGITAL PULSE RATE MONITOR— 510(k) K802204
Substantially EquivalentIndustrial & Biomedical Sensors Corp.
FDA 510(k) clearance K802204 for CT-1600 DIGITAL PULSE RATE MONITOR, Substantially Equivalent on 1980-10-03. Applicant: Industrial & Biomedical Sensors Corp..
Clearance details
- Applicant
- Industrial & Biomedical Sensors Corp.
- Product code
- Code DRT
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Adverse events under product code DRT
product code DRT- Death
- 4
- Total
- 4
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.