FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES
K Number: K910781
·
Decision May 15, 1991
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
31
Applicant Total
31
Review Days
79
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Basic Information
- Device Name
- #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES
- K Number
- K910781
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Midmark Corp.
- Date Received
- February 25, 1991
- Decision Date
- May 15, 1991
- Product Code
- ETF
- 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 |
|---|---|---|---|
| ETF | Unit, Examining/Treatment, Ent | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
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FDA 510(k)
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| K023348 | MIDMARK M9 ULTRACLAVE STEAM STERILIZER | Mar 3, 2003 | Substantially Equivalent |
| K003090 | MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM | Oct 18, 2000 | Substantially Equivalent |
| K992744 | MIDMARK M4*9 EASYCLAVE STEAM STERILIZER | Jan 10, 2000 | Substantially Equivalent |
| K990189 | MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER | Apr 19, 1999 | Substantially Equivalent |
| K936181 | MIDMARK M-11 ULTRACLAVE STEAM STERILIZER | Nov 30, 1994 | Substantially Equivalent |
| K926463 | RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES | Oct 21, 1994 | Substantially Equivalent |
| K934744 | MIDMARK MAGNUM GENERAL SURGICAL TABLE | Mar 28, 1994 | Substantially Equivalent |