FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER
K Number: K962991
·
Decision Sep 12, 1996
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
16
Review Days
42
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Basic Information
- Device Name
- BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER
- K Number
- K962991
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Polymedica Industries, Inc.
- Date Received
- August 1, 1996
- Decision Date
- September 12, 1996
- Product Code
- FLL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | FDA class 2 | General Hospital |
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Other Clearances by Polymedica Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964398 | SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED | Oct 24, 1997 | Substantially Equivalent |
| K971045 | BASIS FLEXIBLE TIP DIGITAL THERMOMETER | May 2, 1997 | Substantially Equivalent |
| K964701 | MITRAFLEX PIGMENTED WOUND DRESSING | Feb 7, 1997 | Substantially Equivalent |
| K963623 | SPYROFLEX PIGMENTED WOUND DRESSING | Oct 25, 1996 | Substantially Equivalent |
| K955383 | SPYROCOLLOID WOUND DRESSING | Dec 13, 1995 | Substantially Equivalent for Some Indications |
| K953885 | SPYROFLEX SKIN PROTECTOR | Nov 29, 1995 | Substantially Equivalent |
| K952756 | MEDI-AID BASAL THERMOMETER | Sep 25, 1995 | Substantially Equivalent |
| K952159 | BASIS DIGITAL THERMOMETER | Sep 22, 1995 | Substantially Equivalent |
| K953618 | SPYROFLEX WOUND DRESSING | Aug 21, 1995 | Substantially Equivalent for Some Indications |
| K951862 | A GEL WOUND DRESSING | Jul 12, 1995 | Substantially Equivalent |