FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SLIMLINE 3000
K Number: K934180
·
Decision Nov 24, 1993
Classifications
1
FEI Numbers
172
Registration Numbers
172
Same Product Code
197
Applicant Total
17
Review Days
89
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Basic Information
- Device Name
- SLIMLINE 3000
- K Number
- K934180
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pymah Corp.
- Date Received
- August 27, 1993
- Decision Date
- November 24, 1993
- Product Code
- DXQ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXQ | Blood Pressure Cuff | FDA class 2 | Cardiovascular |
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Other Clearances by Pymah Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K952995 | ATI ETHYLENE OXIDE STERILIZATION INDICATOR | Feb 22, 1996 | Substantially Equivalent |
| K952408 | ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION | Jul 6, 1995 | Substantially Equivalent |
| K951063 | ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION | May 10, 1995 | Substantially Equivalent |
| K934874 | STERIGAGE EO 100% | Apr 18, 1995 | Substantially Equivalent |
| K943081 | TRIMLINE 2000 | Jan 27, 1995 | Substantially Equivalent |
| K925745 | ATI(R) DISP BIOLOGICAL-PLUS TEST PACK | Feb 1, 1994 | Substantially Equivalent |
| K925496 | ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK | Feb 1, 1994 | Substantially Equivalent |
| K924681 | GLUTARALDEHYDE MONITORS | Nov 17, 1993 | Substantially Equivalent |
| K925744 | TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF | Jul 30, 1993 | Substantially Equivalent |
| K930604 | BALANCED(TM) NYLON BLADDER | Apr 30, 1993 | Substantially Equivalent |