Dobbhoff Anorect Biofeed Syst Five Div Fecal Const
FDA 510(k) K913736 · Biosearch Medical Products, Inc.
510(k) numberK913736
Submission
- Device name
- Dobbhoff Anorect Biofeed Syst Five Div Fecal Const
- Applicant
- Biosearch Medical Products, Inc.
Somerville, NJ, US - Received
- August 20, 1991
- Decision date
- February 7, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FAP – Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1620
- Specialty
- Gastroenterology, Urology
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| K931179 | Urolab SpectrumFAP · Traditional | Life-Tech Intl., Inc. | 11/18/1993SE |
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| K924383 | Synectics Liberty System, PC Polygraf/Polygram UroFAP · Traditional | Synectics-Dantec | 06/18/1993SE |
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| K923464 | Urodynamic CathetersFAP · Traditional | R.L. Medical Corp. | 02/05/1993SE |
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| K944614 | Mega-Brush, Endoscopic Mass Cytology - Celluar Retrieval SystemFDX · Traditional | 04/05/1995SE |
| K932295 | Non-Balloon Replacement Gastrostomy KitKNT · Traditional | 09/08/1994SE |
| K935045 | Biosearch Laproscopic Gastronomy CatheterKNT · Traditional | 08/19/1994SE |
| K923002 | Enteroclysis TubeKNT · Traditional | 06/28/1994SESK |
| K934193 | Cell-Mate(Tm) Mass Cytology-Cellular Retrieval SystEOX · Traditional | 11/19/1993SE |
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Questions and answers
When was Dobbhoff Anorect Biofeed Syst Five Div Fecal Const cleared by the FDA?
Dobbhoff Anorect Biofeed Syst Five Div Fecal Const (K913736) received a 510(k) decision of Substantially Equivalent on February 7, 1992, 171 days after the submission was received.
What is the product code of K913736?
The FDA product code is FAP – Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, a Class II (moderate risk) device regulated under 21 CFR 876.1620.