FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CYPRESS MEDICAL PRODUCTS STETHOSCOPE
K Number: K945082
·
Decision Dec 8, 1994
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
27
Applicant Total
26
Review Days
52
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Basic Information
- Device Name
- CYPRESS MEDICAL PRODUCTS STETHOSCOPE
- K Number
- K945082
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cypress Medical Products, Ltd.
- Date Received
- October 17, 1994
- Decision Date
- December 8, 1994
- Product Code
- LDE
- 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 |
|---|---|---|---|
| LDE | Stethoscope, Manual | FDA class 1 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDE), ordered by most recent decision date.
VARIOUS STETHOSCOPES
FDA 510(k)
FDA Class 1
·Cardiovascular
MANUAL STETOSCOPE
FDA 510(k)
FDA Class 1
·Cardiovascular
PROSCOPES AND ADSCOPES
FDA 510(k)
FDA Class 1
·Cardiovascular
STETHOSCOPE COVER
FDA 510(k)
FDA Class 1
·Cardiovascular
TIMEOSCOPE AND FLEXISCOPE
FDA 510(k)
FDA Class 1
·Cardiovascular
STETHOSCOPE
FDA 510(k)
FDA Class 1
·Cardiovascular
Other Clearances by Cypress Medical Products, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K021676 | CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL | Jul 12, 2002 | Substantially Equivalent |
| K012282 | STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE | Aug 6, 2001 | Substantially Equivalent |
| K972899 | CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER | Jul 7, 1998 | Substantially Equivalent |
| K972849 | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) | May 28, 1998 | Substantially Equivalent |
| K972883 | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) | Feb 26, 1998 | Substantially Equivalent |
| K952367 | CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE | Jul 5, 1995 | Substantially Equivalent |
| K950254 | CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE | Mar 31, 1995 | Substantially Equivalent |
| K950092 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY | Feb 27, 1995 | Unknown |
| K950109 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER | Feb 27, 1995 | Unknown |
| K921988 | LACERATION REPAIR TRAY | Nov 19, 1992 | Unknown |