FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE
K Number: K854751
·
Decision Feb 28, 1986
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
48
Applicant Total
55
Review Days
94
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
- ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE
- K Number
- K854751
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4350
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Aspen Laboratories, Inc.
- Date Received
- November 26, 1985
- Decision Date
- February 28, 1986
- 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 Aspen Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981220 | SYSTEM 7500 ABC ELECTROSURGICAL UNIT | Apr 21, 1998 | Substantially Equivalent |
| K963088 | SHEATH, ELECTROSURGICAL PENCIL | Sep 13, 1996 | Substantially Equivalent |
| K955834 | SYSTEM 6500 ABC ELECTROSURGICAL UNIT | Jul 11, 1996 | Substantially Equivalent |
| K960296 | 4000 ETM | Feb 20, 1996 | Substantially Equivalent |
| K953081 | BEAMER PLUS | Oct 30, 1995 | Substantially Equivalent |
| K953007 | EXCALIBUR PLUS ELECTROSURGICAL UNIT | Aug 21, 1995 | Substantially Equivalent |
| K946104 | SMOKIEVAC ELECTROSURGICAL PENCIL | Apr 3, 1995 | Substantially Equivalent |
| K944012 | ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR | Dec 21, 1994 | Substantially Equivalent |
| K924960 | EXCALIBUR ELECTROSURGICAL UNIT | Apr 16, 1993 | Substantially Equivalent |
| K913213 | SINGLE USE LEE ELECTRODE | Feb 13, 1992 | Substantially Equivalent |