FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIVER MEDICAL MICRODRILL SYSTEM
K Number: K905437
·
Decision May 30, 1991
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
48
Applicant Total
16
Review Days
177
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
- RIVER MEDICAL MICRODRILL SYSTEM
- K Number
- K905437
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4350
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- River Medical, Inc.
- Date Received
- December 4, 1990
- Decision Date
- May 30, 1991
- Product Code
- EQH
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EQH | Source, Carrier, Fiberoptic Light | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EQH), ordered by most recent decision date.
WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
JED-LIGHT FIBEROPTIC LIGHT SOURCE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
COLD LIGHT SOURCE LOS 150
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by River Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023174 | DISPOSABLE TEMPORARY PACING WIRE | Jun 11, 2003 | Substantially Equivalent |
| K944351 | SMARTDOSE IV PREFILLED INFUSION CONTAINER | Nov 15, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K944352 | SMARTDOSE III INFUSION CONTAINER | Nov 15, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K945298 | SMARTFLOW I ADMINISTRATION SET | Jun 14, 1995 | Substantially Equivalent |
| K943692 | SMART DOSE(TM) | Apr 28, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K932895 | RIVER PUMP | Mar 31, 1994 | Substantially Equivalent |
| K933335 | RIVER VIAL ADAPTER | Mar 1, 1994 | Substantially Equivalent |
| K915120 | TEF/PLATINUM PISTON | Dec 27, 1991 | Substantially Equivalent |
| K915121 | TEF/WIRE PISTON | Dec 23, 1991 | Substantially Equivalent |
| K913287 | H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET | Dec 18, 1991 | Substantially Equivalent |