FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOPPLER ULTRASONIC STETHOSCOPE
K Number: K801512
·
Decision Aug 20, 1980
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
20
Review Days
51
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Basic Information
- Device Name
- DOPPLER ULTRASONIC STETHOSCOPE
- K Number
- K801512
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Mountain Medical Equipment, Inc.
- Date Received
- June 30, 1980
- Decision Date
- August 20, 1980
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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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 |
| K893531 | CUFF SPECULUM | Jun 22, 1989 | 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 |