MODELS DPT 1000/DPT 1000NS— 510(k) K823286
Substantially EquivalentBio-Med Corp.
FDA 510(k) clearance K823286 for MODELS DPT 1000/DPT 1000NS, Substantially Equivalent on 1982-12-30. Applicant: Bio-Med Corp.. Device class: 2.
Clearance details
- Applicant
- Bio-Med Corp.
- 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
- Walker, MI, US
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More clearances from Bio-Med Corp.
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.