Disposable Patient Blanket
FDA 510(k) K843038 · Anago, Inc.
510(k) numberK843038
Submission
- Device name
- Disposable Patient Blanket
- Applicant
- Anago, Inc.
Fort Worth, TX, US - Received
- August 2, 1984
- Decision date
- October 24, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KME – Bedding, Disposable, Medical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6060
- Specialty
- General Hospital
Other 510(k)s with product code KME
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042145 | Ready-Heat BlanketKME · Traditional | Techtrade, LLC | 09/17/2004SE |
| K944953 | Orex Medical BeddingKME · Traditional | Thantex Specialties, Inc. | 12/02/1994SE |
| K933636 | Dispose-A-SheetKME · Traditional | Belmac Healthcare Corp. | 01/26/1994SE |
| K932539 | Doctor Down --Rescue WrapKME · Traditional | Three Dog Down | 11/02/1993SE |
| K922143 | American Burn SheetKME · Traditional | American Silk Sutures, Inc. | 08/10/1992SE |
| K915303 | Foil Baby BuntingKME · Traditional | Gam Industries, Inc. | 02/20/1992SE |
| K912257 | Chem-Sleeve BKME · Traditional | Haz-Med, Inc. | 12/31/1991SE |
| K911953 | Medi Guard Sheets/UnderlaysKME · Traditional | Sancella, Inc. | 05/28/1991SE |
| K911952 | Medi Guard UnderpadKME · Traditional | Sancella, Inc. | 05/28/1991SE |
| K911948 | Medi Guard PillowcaseKME · Traditional | Sancella, Inc. | 05/28/1991SE |
More from Sancella, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925659 | U.C.E.Z. Lens Cleaner KitOCT · Traditional | 09/17/1993SE |
| K930161 | Anago Spinal Anesthesia TrayCAZ · Traditional | 07/06/1993SEKD |
| K926590 | Anago Disposable Instant Cold PackIMD · Traditional | 05/26/1993SE |
| K926589 | Anago Warm PackIMD · Traditional | 05/26/1993SE |
| K926137 | Anago Fem-Cool/Fem-Cool PetiteIMD · Traditional | 05/26/1993SE |
| K920615 | Anago Continuous Epidural Anesthesia Tray/KitCAZ · Traditional | 03/20/1993SEKD |
| K915415 | Guardall ShieldLYU · Traditional | 10/15/1992SE |
| K913558 | Reliable Cone Style Face MaskFXX · Traditional | 11/07/1991SE |
| K905865 | Anti-For Surgical Face MaskFXX · Traditional | 03/06/1991SE |
| K905749 | Surgical Face MaskFXX · Traditional | 03/04/1991SE |
Questions and answers
When was Disposable Patient Blanket cleared by the FDA?
Disposable Patient Blanket (K843038) received a 510(k) decision of Substantially Equivalent on October 24, 1984, 83 days after the submission was received.
What is the product code of K843038?
The FDA product code is KME – Bedding, Disposable, Medical, a Class I (low risk) device regulated under 21 CFR 880.6060.