SURELOCK(TM) SNAPLESS MONITORING ELECTRODE— 510(k) K931903
Substantially EquivalentLudlow Technical Products
FDA 510(k) clearance K931903 for SURELOCK(TM) SNAPLESS MONITORING ELECTRODE, Substantially Equivalent on 1993-10-07. Applicant: Ludlow Technical Products. Device class: 2.
Clearance details
- Applicant
- Ludlow Technical Products
- Product code
- Code DRX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2360
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicopee, MA, US
Recent devices under product code DRX
view allMore clearances from Ludlow Technical Products
view all- K991235 — SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)
- K973110 — LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORD
- K972646 — AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES
- K964401 — KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)
Adverse events under product code DRX
product code DRX- Death
- 6
- Injury
- 476
- Other
- 2
- Total
- 484
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.