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#
- 3019848304
- 2435946
- 3015058854
- 3016714803
- 3011707926
- 3010160370
- 3016766901
- 3008311433
- 3017364709
- 3017085595
- 9613558
- 3011587065
- 3006582165
- 1000358138
- 3017417635
- 2022409
- 3005748481
- 3011270181
- 3007084580
- 3016096096
- 3031184338
- 3006891803
- 9615270
- 3013410562
- 3014601456
- 3005090771
- 3011500469
- 3027327527
- 3007710677
- 3010598169
- 2182303
- 3005728058
- 3016970619
- 3011934883
- 9617805
- 3004998166
- 3004127972
- 3006535976
- 3007407626
- 3007479164
- 3005841027
- 3009244023
- 3015219076
- 3010595915
- 3010339057
- 3003561450
- 3021286079
- 1043644
- 3005271071
- 3025430561
- 2087200
- 1933975
- 3017406840
- 3010621964
- 3012267116
- 3043049733
- 3017103765
- 2437780
- 8030607
- 3023339277
- 3033621973
- 3017953189
- 3008374630
- 3007175977
- 3006123105
- 3038138497
- 1417592
- 3006113262
- 3034629649
- 3010014065
- 3010155681
- 3010363542
- 3006973666
- 3013440654
- 3004160996
- 3008808082
- 9615551
- 3006400329
- 3008808123
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#
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
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