FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CUFF SPECULUM
K Number: K893531
·
Decision Jun 22, 1989
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
39
Applicant Total
20
Review Days
45
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Basic Information
- Device Name
- CUFF SPECULUM
- K Number
- K893531
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5220
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Mountain Medical Equipment, Inc.
- Date Received
- May 8, 1989
- Decision Date
- June 22, 1989
- Product Code
- KPL
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KPL | Colonic Irrigation System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Mountain Medical Equipment, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941793 | OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) | Jun 21, 1995 | Substantially Equivalent |
| K923650 | SCOTTY | Jan 15, 1993 | Substantially Equivalent |
| K924684 | MICROFLOW | Dec 15, 1992 | Substantially Equivalent |
| K914916 | ALPINE V | Sep 23, 1992 | Substantially Equivalent |
| K902890 | ASPEN 3 OXYGEN CONCENTRATOR | Jul 19, 1990 | Substantially Equivalent |
| K884084 | PORTABLE OXYGEN GENERATOR | Nov 21, 1988 | Substantially Equivalent |
| K881802 | ALPINE PORTABLE OXYGEN GENERATOR | Jul 8, 1988 | Substantially Equivalent |
| K873677 | ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER | Oct 20, 1987 | Substantially Equivalent |
| K873170 | ARIES | Sep 25, 1987 | Substantially Equivalent |
| K864005 | ALPINE | Jan 28, 1987 | Substantially Equivalent |