510(k) K813298
- Device
- CONPHAR DELEE HILLIS STETHOSCOPE
- Applicant
- CONPHAR, INC.
- 510(k) number
- K813298
- Product code
- HGN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-12-08
- Date received
- 1981-11-23
- Regulation
- 884.2900
- Classification name
- Stethoscope, Fetal
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9680411
- 3007123908
- 2431166
- 3013530901
- 3009703496
- 1836161
- 8040278
- 9681622
- 3013846070
- 3031700059
- 3038632739
- 3003431869
- 9613083
- 3008338766
- 3015143057
- 3003882387
- 3011526299
- 3003877407
- 8040884
- 9616246
- 3003759558
- 8043235
- 3003418325
- 3015895045
- 3031564283
- 3006897996
- 9610612
- 3005273623
- 9610621
- 3002807115
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HGN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K761338 | LEFF STETHOSCOPE FOR FETAL HEART | J. Sklar Mfg. Co., Inc. | 1977-01-12 |
Legacy Summary#
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FDA Review#
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