CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P— 510(k) K101439
Substantially EquivalentCodonics, Inc.
FDA 510(k) clearance K101439 for CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P, Substantially Equivalent on 2011-02-07. Applicant: Codonics, Inc.. Device class: 2.
Clearance details
- Applicant
- Codonics, Inc.
- Product code
- Code BSZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5160
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Middleburg Heights, OH, US
Recent devices under product code BSZ
view allMore clearances from Codonics, Inc.
view all- K060440 — CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER
- K042232 — NP-2600 SERIES HARDCOPY PRINTERS
- K030690 — CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS
- K021054 — CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER
- K003481 — CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660
Adverse events under product code BSZ
product code BSZ- Death
- 23
- Injury
- 298
- Malfunction
- 32,987
- Total
- 33,308
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.