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510(k) K833488

Device
SONICOMP
Applicant
SONICAID, INC.
510(k) number
K833488
Product code
HEM  
Decision
Substantially Equivalent (SESE)
Decision date
1983-11-28
Date received
1983-10-07
Regulation
884.2225
Classification name
Imager, Ultrasonic Obstetric-gynecologic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HEM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K951393ABACUS OB ULTRASOUNG COMPUTER SOFTWARESolomon Technology Labs1995-05-01
K942490BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUNDMedical Soft, Inc.1995-02-15
K910426SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENTShimadzu Medical Systems1991-06-06
K905000ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERCorometrics Medical Systems, Inc.1991-01-31
K900505SONOACE 88 PORTABLE ULTRASOUND SCANNERMedison Co., Ltd.1990-08-10
K900271MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINKDigisonics, Inc.1990-04-19
K890637EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGEElscint, Inc.1989-06-12
K881329FETAL DOPPLER FOR ULTRAMARK 4 AND 8Advanced Technology Laboratories, Inc.1989-04-14
K885061SIEMENS INTRAVAGINAL TRANSDUCERSiemens Medical Solutions USA, Inc.1989-02-23
K881185ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.Philips Medical Systems (Cleveland), Inc.1988-06-01
K880900SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNERCorometrics Medical Systems, Inc.1988-06-01
K862364NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)Swemed Laboratories, Inc.1986-08-19
K862627SONORANGER TRANSVAGINAL PROBEAusonics Pty , Ltd.1986-08-01
K861931645OB SECTOR/LINEAR ULTRASOUND SCANNERGe Medical Systems Information Technologies1986-07-31
K8602335 MHZ INTRACAVITARY PROBE, MODEL H4222VGeneral Electric Co.1986-06-02

Legacy Summary#

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FDA Review#

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