FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEB-TRAVEL NTS-1000 & NTS-3000 THERAPY
K Number: K822685
·
Decision Sep 21, 1982
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
73
Applicant Total
2
Review Days
18
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Basic Information
- Device Name
- NEB-TRAVEL NTS-1000 & NTS-3000 THERAPY
- K Number
- K822685
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.6250
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Certified Respiratory Services, Inc.
- Date Received
- September 3, 1982
- Decision Date
- September 21, 1982
- Product Code
- BTI
- 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 |
|---|---|---|---|
| BTI | Compressor, Air, Portable | FDA class 2 | Anesthesiology |
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Other Clearances by Certified Respiratory Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K822359 | SPI-RISE | Aug 27, 1982 | Substantially Equivalent |