FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HPD HEATER BASES
K Number: K914994
·
Decision Feb 12, 1993
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
42
Applicant Total
6
Review Days
463
Basic Information
- Device Name
- HPD HEATER BASES
- K Number
- K914994
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5270
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- HPD MEDICAL, INC.
- Date Received
- November 7, 1991
- Decision Date
- February 12, 1993
- Product Code
- BZE
- 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 |
|---|---|---|---|
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | FDA class 2 | Anesthesiology |
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Other Clearances by HPD MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K895795 | HPD TUBING CONNECTORS | Jan 26, 1990 | Substantially Equivalent |
| K885314 | HPD STERILE HUMIDIFYING CHAMBER | Jan 17, 1989 | Substantially Equivalent |
| K864173 | HPD HUMIDIFYING CHAMBER | Jan 30, 1987 | Substantially Equivalent |
| K841851 | HPD HUMIDIFIER WICK | Jun 5, 1984 | Substantially Equivalent |
| K821957 | CATH-LOK | Jul 28, 1982 | Substantially Equivalent |