FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NDM INFANT ECG PACKPAD
K Number: K780631
·
Decision May 3, 1978
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
68
Applicant Total
6
Review Days
16
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Basic Information
- Device Name
- NDM INFANT ECG PACKPAD
- K Number
- K780631
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- New Dimensions IN Medicine, Inc.
- Date Received
- April 17, 1978
- Decision Date
- May 3, 1978
- Product Code
- GYB
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GYB | Media, Electroconductive | FDA class 2 | Neurology |
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Other Clearances by New Dimensions IN Medicine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920677 | CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION | Apr 21, 1992 | Substantially Equivalent |
| K832145 | MONOBLOCK PROSTOPERATIVE TENS ELECTRODE | Jul 19, 1983 | Substantially Equivalent |
| K822077 | RESPIRATION MONITOR TYPE MR-10 | Oct 6, 1982 | Substantially Equivalent |
| K780405 | INFANT ELECTROSURGICAL GROUNDING PAD | Apr 5, 1978 | Substantially Equivalent |
| K771749 | AMALGAM DISPENSER | Sep 28, 1977 | Substantially Equivalent |