NOSOGARD FILTERS
FDA 510(k) clearance K153784 · decided 2016-10-21
Clearance details
- K-number
- K153784
- Device name
- NOSOGARD FILTERS
- Applicant
- Evoqua Water Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-12-31
- Decision date
- 2016-10-21
- Days to decision
- 295 days
- Clearance type
- Traditional
- Product code
- NHV
- Device class
- 2
- Regulation number
- 876.5665
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lowell, MA, US
- Third-party review
- No
- Expedited review
- No
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| Pall-Aquasafe Water Filter (K153434) | Pall International Sarl | 2016-06-10 |
| Nephros S100 (K153084) | Nephros, Inc. | 2016-04-08 |
| NEPHROS DSU-H, NEPHROS SSU-H (K141731) | Nephros, Inc. | 2014-10-24 |
| MAINSTREAM WATER PURIFICATION DEVICE (K012716) | Prismedical Corp. | 2002-05-07 |
Recalls involving this device
No recalls on record reference this clearance.