FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DACOMED CYSTOMETER
K Number: K880391
·
Decision Apr 27, 1988
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
7
Applicant Total
20
Review Days
89
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Basic Information
- Device Name
- DACOMED CYSTOMETER
- K Number
- K880391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Dacomed Corp.
- Date Received
- January 29, 1988
- Decision Date
- April 27, 1988
- Product Code
- EXQ
- 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 |
|---|---|---|---|
| EXQ | Cystometer, Electrical Recording | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EXQ), ordered by most recent decision date.
Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))
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FDA Class 2
·Gastroenterology, Urology
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FDA Class 2
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FDA Class 2
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LIFE-TECH #1857 PRESSURE/POLOT MODULE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Dacomed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K953640 | DUNA II PENILE PROSTHESIS | Oct 27, 1995 | Substantially Equivalent |
| K941781 | RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM | Aug 25, 1994 | Substantially Equivalent |
| K920409 | DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE | May 11, 1992 | Substantially Equivalent |
| K920420 | DURA II PENILE PROSTHESIS | Apr 16, 1992 | Substantially Equivalent |
| K912344 | MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS | Oct 11, 1991 | Substantially Equivalent |
| K900774 | DACOMED NEGATIVE PRESSURE ERECTION DEVICE | May 4, 1990 | Substantially Equivalent |
| K885323 | DACOMED EXTERNAL MALE CONTINENCE DEVICE | Feb 8, 1989 | Substantially Equivalent |
| K871653 | DURAPHASE PENILE PROSTHESIS | Sep 18, 1987 | Substantially Equivalent |
| K870320 | DACOMED PENILE PROSTHESIS SIZER | Mar 17, 1987 | Substantially Equivalent |
| K854118 | DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS | Mar 17, 1986 | Substantially Equivalent |