FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR
K Number: K862149
·
Decision Jun 19, 1986
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
62
Applicant Total
110
Review Days
15
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Basic Information
- Device Name
- MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR
- K Number
- K862149
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2775
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Puritan Bennett Corp.
- Date Received
- June 4, 1986
- Decision Date
- June 19, 1986
- Product Code
- BXN
- 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 |
|---|---|---|---|
| BXN | Stimulator, Nerve, Battery-Powered | FDA class 2 | Anesthesiology |
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STIMPOD ST2-3010 NERVE STIMULATOR
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EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
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| K984535 | PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION | Dec 28, 1998 | Substantially Equivalent - Subject to Tracking Reg. |