FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STORZ ENT/OPHTHALMIC MAXI CHAIR
K Number: K870112
·
Decision Feb 12, 1987
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
15
Applicant Total
101
Review Days
31
Basic Information
- Device Name
- STORZ ENT/OPHTHALMIC MAXI CHAIR
- K Number
- K870112
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1140
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- STORZ INSTRUMENT CO.
- Date Received
- January 12, 1987
- Decision Date
- February 12, 1987
- Product Code
- HME
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HME | Chair, Ophthalmic, Ac-Powered | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HME), ordered by most recent decision date.
MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR
FDA 510(k)
FDA Class 1
·Ophthalmic
BREATH-EASY, MODIFICATION
FDA 510(k)
FDA Class 1
·Ophthalmic
RELIANCE(R) 6200 EXAMINATION CHAIR
FDA 510(k)
FDA Class 1
·Ophthalmic
MODEL 6500 OPTHALMIC CHAIR
FDA 510(k)
FDA Class 1
·Ophthalmic
MAC 150E OPTHALMIC CHAIR
FDA 510(k)
FDA Class 1
·Ophthalmic
THE ERGOSYSTEM CHAIR
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by STORZ INSTRUMENT CO.
| K Number | Device Name | ||
|---|---|---|---|
| K980100 | STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK | Jun 1, 1998 | Substantially Equivalent |
| K980488 | STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM | Mar 23, 1998 | Substantially Equivalent |
| K972664 | STORZ MILLENNIUM VISCOUS FLUID SYSTEM | Oct 10, 1997 | Substantially Equivalent |
| K971439 | STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES | Jun 17, 1997 | Substantially Equivalent |
| K964743 | STORZ E8010 ERGOTEC/PREMIERE ADAPTOR | Feb 3, 1997 | Substantially Equivalent |
| K960024 | STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH | Sep 20, 1996 | Substantially Equivalent |
| K960061 | STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE | Sep 18, 1996 | Substantially Equivalent |
| K960003 | STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION | Aug 29, 1996 | Substantially Equivalent |
| K962131 | STORZ D4600 AIR EXCHANGE LINE PACK | Aug 23, 1996 | Substantially Equivalent |
| K961874 | STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK | Aug 6, 1996 | Substantially Equivalent |