FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANS-PACE
K Number: K834262
·
Decision Feb 4, 1984
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
83
Applicant Total
7
Review Days
58
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Basic Information
- Device Name
- TRANS-PACE
- K Number
- K834262
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5550
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Micromedical Devices, Inc.
- Date Received
- December 8, 1983
- Decision Date
- February 4, 1984
- Product Code
- DRO
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | FDA class 2 | Cardiovascular |
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Other Clearances by Micromedical Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K043287 | PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 | Dec 10, 2004 | Substantially Equivalent |
| K936195 | LAPAROSCOPES | Aug 17, 1994 | Substantially Equivalent |
| K936155 | ADAIR INSUFFLATION AND INSTRUMENTATION CANNULA | Apr 11, 1994 | Substantially Equivalent |
| K936097 | VIDEO CAMERAS, ENCOSCOPIC AND SURGICAL | Mar 31, 1994 | Substantially Equivalent |
| K936086 | STERILE VIDEO CAMERA COVER AND DRAPE | Mar 17, 1994 | Substantially Equivalent |
| K850791 | MDI 2000 - PULSE GENERATOR | Jun 19, 1985 | Substantially Equivalent |