510(k) K811915
- Device
- MONITOR/VITAL SIGNS TRAY
- Applicant
- AMERICAN HOSPITAL SUPPLY CORP.
- 510(k) number
- K811915
- Product code
- FME
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-07-28
- Date received
- 1981-07-01
- Regulation
- 880.6265
- Classification name
- Gown, Examination
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- 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#
- 1417592
- 3014683120
- 3024088964
- 3007050292
- 1528695
- 3011091529
- 3012344767
- 3016758972
- 3017840934
- 3010656982
- 3009716062
- 3004585856
- 3006400320
- 3010359088
- 3030645716
- 3008756535
- 3011700820
- 3038131022
- 9611326
- 2024980
- 3017461134
- 3008959420
- 3006891803
- 3015068387
- 3007407626
- 3008374630
- 3014601456
- 1836161
- 3023435669
- 3027327527
- 3016490019
- 3006897996
- 3006973666
- 3029742857
- 3006798117
- 3016970619
- 3012034017
- 1043644
- 3006123105
- 3017364709
- 3005728058
- 3015219076
- 3016452400
- 1053445
- 2182303
- 3002637602
- 3010160370
- 9680357
- 3007175977
- 3025430561
- 3013260641
- 3031184338
- 3005022483
- 8030607
- 3016096058
- 3010595915
- 9615551
- 3016763307
- 3004967902
- 3004105221
- 3017486862
- 3015416207
- 3015960676
- 3011934883
- 2087200
- 3026222938
- 3007029063
- 3010598169
- 3009443860
- 1054380
- 3012841710
- 3007084580
- 3006113262
- 3002957587
- 3003561450
- 3012911667
- 3011556876
- 2183301
- 3038772401
- 3045077467
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FME #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K880385 | KIMBERLY-CLARK PROFESSIONAL JACKET | Kimberly-Clark Corp. | 1988-02-19 |
| K770476 | EXAM GOWN | General Medical Co. | 1977-05-06 |
| K760954 | CROWNTEX EXAM. CAPE & GOWN | Graham Manufacturing Co. | 1976-12-30 |
| K760360 | SHIRT, MITTEN CUFF INFANT | Precept, Inc. | 1976-10-20 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases