FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇱 Israel
LITE-BLADE
K Number: K944428
·
Decision Nov 15, 1994
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
63
Applicant Total
4
Review Days
64
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LITE-BLADE
- K Number
- K944428
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5540
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eare Consulting Service
- Date Received
- September 12, 1994
- Decision Date
- November 15, 1994
- Product Code
- CCW
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CCW | Laryngoscope, Rigid | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CCW), ordered by most recent decision date.
APA Oxy Blade
FDA 510(k)
FDA Class 1
·Anesthesiology
Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)
FDA 510(k)
FDA Class 1
·Anesthesiology
YEESCOPE LARYNGOSCOPES
FDA 510(k)
FDA Class 1
·Anesthesiology
AIRTRAQ SP AIRTRAQ AVANT
FDA 510(k)
FDA Class 1
·Anesthesiology
NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
FDA 510(k)
FDA Class 1
·Anesthesiology
TRU-MR LARYNGOSCOPE SET
FDA 510(k)
FDA Class 1
·Anesthesiology