FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WATER BATH
K Number: K822564
·
Decision Sep 14, 1982
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
11
Applicant Total
3
Review Days
21
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Basic Information
- Device Name
- WATER BATH
- K Number
- K822564
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2540
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Boekel Industries, Inc.
- Date Received
- August 24, 1982
- Decision Date
- September 14, 1982
- Product Code
- JTQ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JTQ | Bath, Incubators/Water, All | FDA class 1 | Microbiology |
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