BAG DECANTER— 510(k) K972134
Substantially EquivalentRemington Medical, Inc.
FDA 510(k) clearance K972134 for BAG DECANTER, Substantially Equivalent on 1997-08-26. Applicant: Remington Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Remington Medical, Inc.
- Product code
- Code LHI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
Recent devices under product code LHI
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- K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
- K212065 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger
- K191315 — Remington Medical, Inc. Automatic Cutting Needle (NAC)
Adverse events under product code LHI
product code LHI- Injury
- 207
- Malfunction
- 7,820
- Other
- 3
- Total
- 8,030
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.