FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTERTECH STERILE WATER FOR INHALATION
K Number: K881184
·
Decision May 25, 1988
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
220
Applicant Total
27
Review Days
65
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INTERTECH STERILE WATER FOR INHALATION
- K Number
- K881184
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5450
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Delmed, Inc.
- Date Received
- March 21, 1988
- Decision Date
- May 25, 1988
- Product Code
- BTT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTT), ordered by most recent decision date.
HVT 2.0
FDA 510(k)
FDA Class 2
·Anesthesiology
FL-10000U Respiratory Humidifier
FDA 510(k)
FDA Class 2
·Anesthesiology
Laboratorios Biogalenic Sterile Water for Inhalation, USP
FDA 510(k)
FDA Class 2
·Anesthesiology
Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
FDA 510(k)
FDA Class 2
·Anesthesiology
Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
FDA 510(k)
FDA Class 2
·Anesthesiology
Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Delmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895142 | ENTERAL PUMP SET WITH ENTERAL SPIKE | Oct 2, 1990 | Substantially Equivalent |
| K895650 | ENTERAL PUMP SET W/ENTERA-FLO SPIKE | Oct 2, 1990 | Substantially Equivalent |
| K895329 | 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA | Oct 2, 1990 | Substantially Equivalent |
| K894506 | ENTERA-FLO ENTERAL FEEDING PUMP | Aug 6, 1990 | Substantially Equivalent |
| K901478 | DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION | Jul 27, 1990 | Substantially Equivalent |
| K901477 | DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION | Jul 27, 1990 | Substantially Equivalent |
| K900106 | CLOSED DISCONNECT SYSTEM | Jul 16, 1990 | Substantially Equivalent |
| K895246 | FRENTA(R) DUO-SET | May 2, 1990 | Substantially Equivalent |
| K895330 | 600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA | May 2, 1990 | Substantially Equivalent |
| K895919 | ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III | May 2, 1990 | Substantially Equivalent |