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#
- 9617805
- 3004158259
- 3009540572
- 3008311433
- 9615551
- 3005728058
- 3017364709
- 3010598169
- 3012034017
- 3012911667
- 3034669683
- 3006942361
- 9680357
- 3005748481
- 1933975
- 2431345
- 3010155681
- 3030645716
- 3008191396
- 3005090771
- 2022409
- 3013026943
- 3009233038
- 9616096
- 2182318
- 3011529314
- 3016714803
- 9614075
- 2030624
- 3017486862
- 3021286079
- 3043049733
- 1528695
- 3007479164
- 3006123105
- 3015167798
- 3013427445
- 3013260641
- 3009155756
- 3011497662
- 3009716062
- 3023435669
- 3014421917
- 3013410562
- 3003495693
- 3030089808
- 3005246188
- 3010162721
- 3027327527
- 3008466086
- 3004105221
- 3017103765
- 3015960676
- 3004967902
- 3002637602
- 3017408377
- 3004133257
- 2032476
- 3015906773
- 3008856821
- 3006535976
- 8030607
- 1054380
- 3017953189
- 3013006775
- 3038772401
- 3038131022
- 3010653892
- 3011587065
- 2027804
- 3008518409
- 3017398283
- 3016096096
- 3010656982
- 3016452400
- 2432177
- 2648727
- 3008008970
- 3016096058
- 3005841027
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