FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MEDI-AID BASAL THERMOMETER
K Number: K952756
·
Decision Sep 25, 1995
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
23
Applicant Total
16
Review Days
101
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Basic Information
- Device Name
- MEDI-AID BASAL THERMOMETER
- K Number
- K952756
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Polymedica Industries, Inc.
- Date Received
- June 16, 1995
- Decision Date
- September 25, 1995
- Product Code
- LHD
- Advisory Committee
- Unknown
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| LHD | Device, Fertility Diagnostic, Proceptive | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LHD), ordered by most recent decision date.
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FDA Unclassified
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DUOFERTILITY
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FDA Unclassified
·Unknown
LADY COMP USA
FDA 510(k)
FDA Unclassified
·Unknown
MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921
FDA 510(k)
FDA Unclassified
·Unknown
PETIT SOPHIA
FDA 510(k)
FDA Unclassified
·Unknown
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 |
| K962991 | BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER | Sep 12, 1996 | Substantially Equivalent |
| K955383 | SPYROCOLLOID WOUND DRESSING | Dec 13, 1995 | Substantially Equivalent for Some Indications |
| K953885 | SPYROFLEX SKIN PROTECTOR | Nov 29, 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 |