GRAHAM-FIELD ULTRASOUND SCANNING GEL— 510(k) K944597
Substantially EquivalentChester Labs, Inc.
FDA 510(k) clearance K944597 for GRAHAM-FIELD ULTRASOUND SCANNING GEL, Substantially Equivalent on 1995-06-21. Applicant: Chester Labs, Inc.. Device class: 2.
Clearance details
- Applicant
- Chester Labs, Inc.
- Product code
- Code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Erlanger, KY, US
Recent devices under product code IYO
view allMore clearances from Chester Labs, Inc.
view all- K041060 — E-Z LUBRICATING JELLY
- K001705 — STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF
- K001593 — MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL
- K944598 — GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL
- K944599 — GRAHAM-FIELD CONDUCTIVE ECG SPRAY
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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.