FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
K Number: K033614
·
Decision Jul 29, 2004
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
176
Applicant Total
55
Review Days
255
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Basic Information
- Device Name
- MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
- K Number
- K033614
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Northgate Technologies, Inc.
- Date Received
- November 17, 2003
- Decision Date
- July 29, 2004
- Product Code
- HIF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | FDA class 2 | Obstetrics/Gynecology |
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| K120151 | NEBULAE I | Aug 17, 2012 | Substantially Equivalent |
| K041560 | FLO-ASSISTANT | Sep 28, 2004 | Substantially Equivalent |
| K022052 | 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 | Jan 24, 2003 | Substantially Equivalent |
| K010053 | HUMI-FLOW, MODEL 6-850-00/ 01/02 | Oct 23, 2001 | Substantially Equivalent |
| K011928 | HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 | Aug 10, 2001 | Substantially Equivalent |
| K001325 | FLO ASSISTANT, MODEL 4-250-00 | Aug 18, 2000 | Substantially Equivalent |
| K993778 | HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 | Jan 6, 2000 | Substantially Equivalent |