FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROTECTAIDE CPR PROTECTION PACK NO. 22100
K Number: K942468
·
Decision Oct 31, 1994
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
102
Applicant Total
11
Review Days
159
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Basic Information
- Device Name
- PROTECTAIDE CPR PROTECTION PACK NO. 22100
- K Number
- K942468
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5870
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Protectaide, Inc.
- Date Received
- May 25, 1994
- Decision Date
- October 31, 1994
- Product Code
- CBP
- 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 |
|---|---|---|---|
| CBP | Valve, Non-Rebreathing | FDA class 2 | Anesthesiology |
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FDA Class 2
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Other Clearances by Protectaide, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942469 | PROTECTAIDE CPR PROTECTION PACK | Oct 31, 1994 | Substantially Equivalent |
| K942475 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 12351 | Oct 18, 1994 | Substantially Equivalent |
| K942474 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000 | Oct 18, 1994 | Substantially Equivalent |
| K942473 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 24592 | Oct 18, 1994 | Substantially Equivalent |
| K942472 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 26123 | Oct 18, 1994 | Substantially Equivalent |
| K942471 | PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. 29777 | Oct 18, 1994 | Substantially Equivalent |
| K942476 | PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. B3069 | Oct 18, 1994 | Substantially Equivalent |
| K942470 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 08315 | Oct 18, 1994 | Substantially Equivalent |
| K942467 | PROTECTAIDE AVIATOR CPR PROTECTION PACK NO. 31000 | Oct 6, 1994 | Substantially Equivalent |
| K942466 | PROTECTAIDE CPR PROTECTION PACK NO. 17701 | Oct 6, 1994 | Substantially Equivalent |