510(k) K870662
- Device
- MODEL SKCK STERILE KNOB COVER KIT
- Applicant
- LIFE-TECH INTL., INC.
- 510(k) number
- K870662
- Product code
- BXM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-10-28
- Date received
- 1987-02-19
- Regulation
- 868.2775
- Classification name
- Stimulator, Nerve, Ac-powered
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDREW C KYLE
- Address
- P.O. Box 36221 Houston TX US 77236 77236
FDA Registration Numbers#
- 2032098
- 2031966
- 3030412764
- 2011115
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BXM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K013215 | MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM | Nuvasive, Inc. | 2001-10-16 |
| K002677 | NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM | Nuvasive, Inc. | 2000-11-13 |
| K921498 | VER MED A10011 PNS DUAL ELEMENT ELECTRODE | Vermont Medical, Inc. | 1993-06-09 |
Legacy Summary#
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FDA Review#
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